EU MDR and IVDR Engagement Case Studies: Field Reports from European Partner Practices (2026)

Quick answer

What do EU MDR and IVDR engagement case studies from European partner practices show in 2026?

Five confidential field reports from partner practices across Spain, Ireland, Poland, Denmark, and Belgium illustrate regulatory machinery that receives little attention in general guidance: the Article 117 medicinal consultation for drug-device combinations, IVDR Class D EU reference laboratory involvement and batch verification, the Class I up-classification trap (including Class Ir reusable instruments), the Article 54 clinical evaluation consultation with an expert panel, and the collapse of own-brand labelling (OBL) arrangements under MDR Articles 10 and 16. Across cases, binding constraints were often external queues, documentation format, portfolio rationalisation, and contractual leverage — not device safety or engineering quality.

Keywords: EU MDR case study, IVDR Class D case study, Article 117 drug-device combination, Article 54 clinical evaluation consultation, MDR expert panel, Class I to Class Ir reclassification, own brand labelling MDR, OBL PLM technical documentation, EU reference laboratory IVDR, batch verification Class D, Notified Body clock stopper, MDR legacy device transition, drug-coated balloon CE mark, active implantable neurostimulator MDR, European medical device regulatory affairs

1. Introduction

The following five engagement reports were contributed by partner practices operating across the European regulatory market. They span five member states, four device classes, and both the MDR and IVDR frameworks. Each covers the manufacturer profile, engagement scope and duration, product characteristics, the regulatory pathway navigated, the substance of authority and Notified Body correspondence, and the remediation applied.

They have been selected to illustrate regulatory machinery that receives comparatively little attention in general guidance: the Article 117 medicinal consultation for drug-device combinations, the Article 54 clinical evaluation consultation procedure, IVDR Class D reference laboratory involvement, the Class I up-classification trap, and the collapse of own-brand labelling arrangements under MDR.

Manufacturer identities and partner practice names are withheld under engagement confidentiality. Product descriptions have been generalised where necessary to prevent identification.

2. Case Study 1 — Spain: Class III Drug-Coated Balloon and the Article 117 Consultation

2.1 Client Profile

2.2 Project Scope and Duration

The engagement covered MDR classification confirmation, drug-device combination strategy, coordination of the Article 117 medicinal consultation, clinical evidence expansion, technical documentation restructuring, and Notified Body liaison through to certificate issuance.

Duration: 34 months. The Article 117 consultation alone consumed 11 months of that total, running partially in parallel with the Notified Body technical review but gating final certification. The manufacturer's original internal projection had been 18 months.

2.3 Product Characteristics

2.4 The Registration Process and Regulatory Strategy

The classification was not in dispute — Rule 14 applies unambiguously to a device incorporating a medicinal substance acting ancillary to the device's principal mode of action. What the manufacturer had not appreciated was the procedural consequence: under MDR Article 52(3) in conjunction with Annex IX Section 5.2, and the consultation obligation established at Article 117 amending Directive 2001/83/EC, the Notified Body cannot conclude the conformity assessment without seeking a scientific opinion on the quality, safety, and usefulness of the medicinal substance from either a national competent authority for medicines or the European Medicines Agency.

The strategic decisions were three.

Choice of consulted authority. The manufacturer elected consultation with the Spanish Agency for Medicines and Medical Devices rather than the EMA. The reasoning was linguistic and procedural familiarity, and the assessment that a national authority queue was shorter than the EMA's for an established molecule. In retrospect the practice assessed this as marginally correct — the national route saved an estimated three to four months relative to a centralised opinion, though this margin varies by authority workload and should not be assumed.

Dossier construction for the medicinal component. The consultation dossier was structured to Common Technical Document conventions for the drug substance sections rather than to device technical documentation conventions. This was a deliberate decision made at month two. Medicines assessors read CTD-structured submissions; presenting drug substance data inside a device technical file format had generated queries in two prior engagements handled by the same practice.

Sequencing the consultation. The Article 117 dossier was submitted at month nine, approximately three months after Notified Body technical file submission, rather than simultaneously. This allowed the Notified Body's initial device-level queries to be resolved before the medicines authority engaged, reducing the risk of inconsistent responses across two parallel review streams.

2.5 Health Authority and Notified Body Interaction

Notified Body correspondence generated 41 findings across two rounds. The substantive concentration was on clinical evidence. The reviewer required the manufacturer to address the paclitaxel mortality signal that emerged from meta-analysis of paclitaxel-coated device trials, notwithstanding subsequent reassessment of that signal. The reviewer's position was that a Class III device incorporating paclitaxel must engage the published mortality literature directly within the benefit-risk determination rather than cite subsequent regulatory reassessment as settling the question. This added a structured meta-analytic appendix to the Clinical Evaluation Report and extended the review by approximately five months.

The reviewer additionally required justification of drug load selection, specifically evidence supporting 3.0 μg/mm² over lower densities, on the basis that GSPR 10.2 requires the medicinal substance quantity to be justified with respect to intended purpose.

Medicines authority correspondence under Article 117 was narrower in scope but more technically demanding within that scope. Three areas dominated.

On drug substance quality, the authority requested the full impurity profile of the paclitaxel API including qualification of a specified degradation product at levels above the ICH Q3A identification threshold. The manufacturer's supplier documentation was insufficient and required a supplementary qualification study.

On elution kinetics, the authority requested in vitro release characterisation under physiologically representative conditions and correlation with the in vivo pharmacokinetic data submitted. The manufacturer's existing release data had been generated under a simplified protocol adequate for device-level performance characterisation but not for a medicinal quality assessment.

On excipient justification, the carrier excipient required qualification data addressing local tolerance, which the manufacturer had considered covered by biocompatibility testing under ISO 10993. The authority's position was that ISO 10993 biological evaluation addresses device material biocompatibility and does not substitute for excipient safety qualification in a medicinal context.

The scientific opinion returned favourable at month 26 with two conditions, both relating to post-market pharmacovigilance-style reporting of paclitaxel-attributable events.

2.6 Pitfalls and Solutions

Pitfall: the Article 117 consultation was absent from the project plan. The manufacturer's regulatory team had planned the engagement as a Class III device transition and had not identified the mandatory medicinal consultation until the Notified Body raised it at the pre-submission meeting.

Solution. The consultation was inserted into the project plan at month two with a dedicated workstream and a separate budget line. The practice's standing recommendation following this engagement is that any device incorporating a medicinal substance be screened for Rule 14 applicability at project initiation, and that the consultation be treated as a parallel regulatory submission with its own timeline, dossier standard, and responsible owner — not as a Notified Body administrative step.

Pitfall: device-format drug data. The initial drug substance documentation was structured as a section of the device technical file.

Solution. Restructured to CTD Module 3 conventions for drug substance and drug product sections. This required engaging a pharmaceutical regulatory writer, a discipline absent from the manufacturer's team. The additional cost was approximately €55,000 and was assessed as having saved at least one full query round.

Pitfall: supplier documentation inadequate for medicinal assessment. The paclitaxel API supplier had provided a Certificate of Analysis and a device-grade specification, not a Drug Master File or equivalent quality dossier.

Solution. A supplier qualification exercise was conducted and the impurity qualification study commissioned directly, at manufacturer cost, because the supplier declined to release proprietary process data. This is a structural exposure for device manufacturers sourcing APIs from suppliers oriented to non-pharmaceutical customers, and the practice now advises API supply agreement review — specifically the right to reference or obtain quality documentation — before Rule 14 device development commences.

Pitfall: clinical literature the manufacturer considered closed.

Solution. Rather than arguing that subsequent regulatory reassessment had settled the paclitaxel mortality question, the CER engaged the primary literature directly, presented an independent meta-analytic re-examination restricted to femoropopliteal indications, and stated residual uncertainty explicitly in the benefit-risk conclusion with a corresponding PMCF objective. The practice's assessment is that arguing a literature signal is closed is consistently less effective before Notified Bodies than addressing it and bounding it.

3. Case Study 2 — Ireland: IVDR Class D Blood Screening Assay and Reference Laboratory Involvement

3.1 Client Profile

3.2 Project Scope and Duration

Scope covered IVDR Class D classification confirmation, performance evaluation dossier construction, common specifications gap assessment, EU reference laboratory engagement, batch verification procedure establishment, and Notified Body conformity assessment.

Duration: 29 months, of which the transitional certificate expiry created a hard commercial deadline at month 14. The practice was engaged at month zero with an already-compressed runway.

3.3 Product Characteristics

3.4 The Registration Process and Regulatory Strategy

Class D is the only IVDR class attracting the full apparatus of supranational oversight, and the engagement was shaped by three obligations that do not apply below Class D.

Common specifications. Under IVDR Article 9, where common specifications have been adopted for a device category, the manufacturer must comply or justify an equivalent or higher level of safety and performance. Common specifications applicable to HIV screening assays impose defined analytical sensitivity requirements and specified reference panel testing.

EU reference laboratory verification. Under Article 48(3) and Article 100, Class D devices require verification of declared performance and compliance with common specifications by a designated EU reference laboratory. This is a distinct assessment from the Notified Body's, conducted by a separate body, on a separate timeline, and it cannot be waived.

Batch verification. Under Article 48(4), the Notified Body verifies each manufactured batch of Class D devices through review of batch release testing and, where common specifications require, reference laboratory batch testing.

The strategy prioritised reference laboratory engagement above all else. The practice's assessment, based on the transitional deadline, was that EU reference laboratory capacity for HIV assay verification was the binding constraint on the entire project, and that any sequencing which placed the reference laboratory submission late would fail the deadline regardless of how efficiently other workstreams executed. Reference laboratory contact was initiated at week three, before the performance evaluation dossier was complete, to secure a queue position.

Performance evaluation was structured per Annex XIII with particular attention to the seroconversion panel and analytical sensitivity requirements specified in the applicable common specifications. The FDA PMA dossier provided substantial usable analytical performance content; it did not address common specifications panel testing, which is a European-specific requirement.

3.5 Health Authority, Notified Body, and Reference Laboratory Interaction

Notified Body correspondence produced 28 findings. The dominant theme was traceability between the performance evaluation report and the underlying raw data, with the reviewer requiring source data verification for a sample of reported analytical sensitivity results. Three discrepancies were identified between reported and source values, all attributable to transcription during dossier assembly rather than to underlying data integrity problems. The reviewer nonetheless required a full data verification exercise across the analytical performance section and a CAPA addressing dossier assembly controls.

EU reference laboratory correspondence was the more consequential interaction. The laboratory's verification testing identified that the assay's analytical sensitivity for a specific HIV-1 subtype — group M subtype CRF02_AG — fell marginally below the threshold specified in the applicable common specifications, at 0.94 IU/mL against a specified requirement of 0.80 IU/mL. The manufacturer's own testing had recorded 0.78 IU/mL for the same panel member. Investigation established that the discrepancy arose from a difference in panel material handling: the reference laboratory had tested panel aliquots following a specified freeze-thaw protocol, while the manufacturer's internal validation had used freshly reconstituted material. The manufacturer's result was not fabricated; it was generated under conditions that did not reflect the reference protocol.

The reference laboratory declined to accept the manufacturer's protocol as equivalent, and required either reformulation to meet the specification under reference conditions or a formal justification of equivalent safety under Article 9.

Competent authority interaction was limited to the Health Products Regulatory Authority in the context of the transitional certificate and did not extend to substantive assessment, Class D assessment being reserved to the Notified Body and reference laboratory.

3.6 Pitfalls and Solutions

Pitfall: reference laboratory capacity treated as a scheduling matter rather than the critical path.

Solution. Early queue engagement at week three. The practice's post-engagement assessment is that a submission entering the reference laboratory queue six months later would have missed the transitional deadline by approximately four months, with consequent loss of market presence and an estimated €6 million revenue impact. Designated reference laboratory capacity for high-volume Class D categories is finite and should be secured before dossier completion.

Pitfall: analytical sensitivity discrepancy under reference conditions.

Solution. Two remediation tracks were run in parallel rather than sequentially, on the assessment that the deadline did not permit waiting to see whether the justification route succeeded. Track one submitted an Article 9 equivalence justification arguing that performance under fresh-material conditions better reflected clinical use, with supporting data on donor specimen stability. Track two initiated a conjugate concentration reformulation to improve subtype CRF02_AG sensitivity under reference conditions. Track one was rejected at month 19. Track two succeeded, achieving 0.71 IU/mL under reference protocol at month 23, and became the basis for certification. The parallel-track decision preserved the deadline; a sequential approach would not have.

Pitfall: internal validation protocols not aligned to reference laboratory protocols. The root cause of the sensitivity discrepancy.

Solution. All internal analytical validation protocols were revised to mirror reference laboratory panel handling conventions, including freeze-thaw treatment, aliquot volume, and reconstitution timing. The practice now advises Class D manufacturers to obtain and adopt reference laboratory testing protocols before generating internal performance data, rather than generating data first and reconciling afterwards.

Pitfall: batch verification procedure absent. The manufacturer had operated notified body batch release under IVDD Annex II List A but the procedure did not meet Article 48(4) requirements regarding documentation and reference laboratory batch testing interface.

Solution. A revised batch verification procedure was established defining batch release testing scope, Notified Body submission content and timing, reference laboratory batch testing triggers, and release-hold decision authority. Because Class D batch verification is a recurring operational obligation rather than a one-time certification activity, the procedure was integrated into manufacturing release workflow rather than held as a regulatory affairs document.

4. Case Study 3 — Poland: The Class I Up-Classification Trap

4.1 Client Profile

4.2 Project Scope and Duration

Scope covered portfolio-wide MDR reclassification assessment, ISO 13485 implementation, Notified Body selection and engagement for the up-classified subset, technical documentation for reclassified items, and portfolio rationalisation strategy.

Duration: 27 months. The engagement began 8 months after the manufacturer had discovered the reclassification exposure, by which point the MDD self-certified declarations for the affected items were no longer a lawful basis for placing on the market.

4.3 Product Characteristics

4.4 The Registration Process and Regulatory Strategy

This engagement addressed the most widespread structural exposure created by the MDD-to-MDR transition. Under the MDD, reusable surgical instruments were Class I and self-certifiable without notified body involvement. Under MDR, Class Ir was created: reusable surgical instruments remain Class I but require Notified Body involvement limited to the aspects of reprocessing — cleaning, disinfection, sterilisation, maintenance, and functional testing. Separately, several instrument categories up-classified beyond Class I entirely under revised Annex VIII rules.

The manufacturer had assumed, as many Class I manufacturers did, that Class I status carried forward unchanged and that the MDR transition was therefore a documentation refresh. It was not. For 271 of 340 catalogue items, a Notified Body relationship became mandatory where none had existed, and the manufacturer possessed no ISO 13485 certification.

The strategy had two phases.

Phase one: portfolio rationalisation. Rather than transitioning the full catalogue, each item was assessed against commercial contribution and transition cost. Sixty-nine items — collectively 4.1% of revenue — were discontinued on the assessment that per-item transition cost exceeded lifetime remaining margin. This was the single most consequential decision in the engagement. Attempting a 340-item transition with 62 FTE and no notified body relationship was assessed as not deliverable.

Phase two: grouping strategy. The retained portfolio was organised into device groups and families to minimise the number of discrete technical documentation sets and Notified Body assessment units. Instruments sharing material specification, reprocessing validation, and intended purpose category were grouped, reducing 271 items to 34 technical documentation sets.

For the 47 Class IIa and 6 Class IIb items, Annex IX conformity assessment applied. For the 218 Class Ir items, Notified Body involvement was scoped to reprocessing aspects under Annex IX Section 5, a materially narrower assessment.

4.5 Health Authority and Notified Body Interaction

Notified Body correspondence on the Class Ir subset concentrated almost entirely on reprocessing validation. The reviewer required, for each device group, validated cleaning and disinfection instructions, sterilisation validation, evidence supporting the stated maximum number of reprocessing cycles, and functional testing demonstrating retained performance at end of stated life.

The manufacturer's existing reprocessing instructions had been carried forward from the MDD era and were generic across the catalogue — a single reprocessing instruction document applied to all instruments. The reviewer rejected this on the basis that reprocessing validation must reflect the specific geometry and material of the device, and that instruments with lumens, hinges, or box joints present cleaning challenges not addressed by a generic instruction.

A second substantial finding concerned maximum reprocessing cycle claims. The manufacturer's instructions stated no cycle limit. The reviewer required either a validated cycle limit supported by functional and material testing, or justification for an unlimited claim. The manufacturer had no data.

On the Class IIa and IIb subset, findings additionally addressed clinical evaluation, where the manufacturer had assumed that well-established surgical instrument categories required no clinical evaluation. The reviewer's position was that Article 61 requires clinical evaluation for every device irrespective of maturity, though for well-established technologies a literature-based evaluation without clinical investigation was acceptable under Article 61(10) with appropriate justification.

Competent authority interaction with the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products concerned the period during which affected items had been placed on the market without a valid basis. The manufacturer made a voluntary disclosure at month four. The authority required a documented corrective action plan and a recall assessment; on the basis that no safety concern was identified and the non-compliance was procedural, no market withdrawal was required for stock already distributed, though further placing on the market was prohibited pending certification.

4.6 Pitfalls and Solutions

Pitfall: assuming Class I status carried forward. The originating error, and one shared across a large population of MDD Class I manufacturers.

Solution. A full portfolio reclassification assessment against MDR Annex VIII, item by item, with documented rationale per item. The practice's standing advice is that any manufacturer holding MDD Class I self-certified declarations should conduct a documented Annex VIII reassessment rather than assuming continuity, and that reusable surgical instruments, software, and devices incorporating measuring functions are the highest-probability up-classification categories.

Pitfall: generic reprocessing instructions.

Solution. Reprocessing validation was restructured by device group with geometry-specific protocols. Instruments with lumens, hinges, and box joints were separated into distinct validation groups with worst-case device selection within each. Cleaning validation used protein residue and bioburden endpoints on artificially soiled worst-case devices. This was the largest single cost element of the engagement at approximately €310,000 across 34 groups.

Pitfall: unlimited reprocessing cycle claims with no supporting data.

Solution. Cycle limit validation was executed on worst-case devices per group, subjecting instruments to repeated validated reprocessing with functional testing and dimensional and surface inspection at defined intervals. Validated limits between 150 and 500 cycles were established by group and stated in revised instructions. The practice notes that stating a validated finite limit is materially cheaper than substantiating an unlimited claim, and that manufacturers frequently default to unlimited claims without recognising the evidentiary burden this creates.

Pitfall: portfolio scale exceeding organisational capacity.

Solution. Discontinuation of 69 low-contribution items and grouping of the remainder. The practice's assessment is that portfolio rationalisation is the most underused MDR transition strategy among small and mid-size manufacturers, who frequently attempt full-catalogue transitions on the assumption that discontinuation represents failure. In this engagement, discontinuing 20% of the catalogue for 4.1% of revenue made the remaining 96% of revenue deliverable.

5. Case Study 4 — Denmark: Class III Active Implantable and the Article 54 Expert Panel

5.1 Client Profile

5.2 Project Scope and Duration

Scope covered technical documentation compilation, clinical evaluation, Notified Body conformity assessment, management of the Article 54 clinical evaluation consultation procedure, and post-market surveillance and PMCF programme design.

Duration: 38 months from engagement to certificate. The Article 54 consultation procedure accounted for approximately 7 months of that total and was the least predictable element.

5.3 Product Characteristics

5.4 The Registration Process and Regulatory Strategy

The engagement was defined by exposure to MDR Article 54, the clinical evaluation consultation procedure. Where a Class III implantable device is subject to conformity assessment and does not fall within the exemptions at Article 54(2), the Notified Body must notify the competent authorities and submit the manufacturer's clinical evaluation assessment report to an expert panel convened under Article 106. The panel may issue a scientific opinion. The Notified Body must give due consideration to that opinion and, where it departs from it, provide a full justification.

The exemptions at Article 54(2) — devices certified under an earlier equivalent conformity assessment, and devices for which common specifications exist — did not apply. A novel closed-loop mechanism in a serious indication was, in the practice's assessment at project initiation, close to a certainty for panel referral.

The strategy therefore treated the expert panel not as a risk to be managed reactively but as an audience to be addressed in the primary submission.

Anticipatory dossier construction. The clinical evaluation was written on the assumption that a panel of independent clinical experts in epileptology and functional neurosurgery would read it. This meant explicit articulation of the clinical question, transparent presentation of the pivotal trial's limitations, direct engagement with alternative therapeutic options including vagus nerve stimulation and deep brain stimulation, and an explicit statement of what the evidence did not establish.

Pre-emptive comparator analysis. Rather than waiting for the panel to ask how the device compared to existing neuromodulation options, a structured indirect comparison was included in the initial submission, with a documented statement of its methodological limitations.

Long-term data strategy. Because the pivotal dataset extended to 24 months and the device is a permanent implant, a PMCF programme with defined long-term endpoints was submitted as part of the primary dossier rather than developed after certification.

5.5 Health Authority, Notified Body, and Expert Panel Interaction

Notified Body correspondence generated 63 findings across three rounds. Substantive concentrations were on the closed-loop algorithm — specifically validation of the seizure detection algorithm's sensitivity and false-positive rate, and the risk management treatment of detection failure — and on lead migration and fracture risk over the implant's stated service life.

A notable finding concerned clinician programming software, which the reviewer assessed as requiring its own software lifecycle documentation under IEC 62304 at safety class C, on the basis that programming errors could result in inappropriate stimulation parameters with potential for serious harm. The manufacturer had documented it at class B.

Expert panel interaction under Article 54 produced a scientific opinion at month 31. The panel's opinion was broadly supportive of the benefit-risk determination but raised three matters.

First, the panel questioned the generalisability of the pivotal population to the proposed indication wording, noting that the trial population had a higher proportion of temporal lobe onset than the indication as drafted would permit, and that evidence for extratemporal onset zones was thinner. The panel suggested the indication either be narrowed or the residual uncertainty stated.

Second, the panel commented on comparative positioning, observing that the indirect comparison against existing neuromodulation options was methodologically limited and should not support comparative efficacy claims. The panel recommended that labelling avoid comparative language.

Third, the panel raised long-term battery and explant considerations, noting that closed-loop operation produces variable battery depletion and that the stated service life range was wide. The panel recommended PMCF endpoints addressing actual service life distribution.

The Notified Body accepted all three points. The manufacturer did not contest them.

Competent authority interaction with the Danish Medicines Agency had occurred earlier in the clinical investigation phase and was not substantive during conformity assessment, Article 54 notification being a Notified Body obligation.

5.6 Pitfalls and Solutions

Pitfall: Article 54 timeline unpredictability. Panel referral, deliberation, and opinion issuance are not bounded by a manufacturer-controllable schedule.

Solution. The engagement plan carried an explicit 6-to-9-month contingency for the consultation procedure, and workstreams that could proceed independently — PMCF programme build, EUDAMED registration, launch preparation, market access dossier development — were scheduled into that window rather than sequenced after certification. This converted the panel period from dead time into parallel productive time. The practice's assessment is that manufacturers who treat Article 54 as a queue to be waited out lose the equivalent of two to three quarters of commercial preparation.

Pitfall: indication wording broader than pivotal evidence.

Solution. The indication was narrowed to specify well-localised onset zones and residual uncertainty regarding extratemporal onset was stated explicitly in the Instructions for Use, with a corresponding PMCF objective to characterise performance by onset zone location. The practice's position, reinforced by this engagement, is that a narrower indication supported by evidence is commercially superior to a broader indication that attracts panel criticism and delays certification — the broader indication can be pursued through post-certification change management once PMCF data supports it.

Pitfall: comparative claims not sustainable on indirect comparison.

Solution. All comparative efficacy language was removed from labelling and promotional material. The indirect comparison was retained in the CER as context for the benefit-risk determination but explicitly not as a basis for claims. Article 7 prohibits misleading claims regarding performance, and a comparative claim resting on an indirect comparison the manufacturer's own dossier describes as methodologically limited is difficult to defend.

Pitfall: programming software safety classification.

Solution. The clinician programming software was reclassified to IEC 62304 safety class C and the software lifecycle documentation upgraded accordingly, including additional verification against class C requirements. This added approximately four months. The practice notes that accessory and companion software to implantable devices is frequently under-classified, and that the relevant question is the harm achievable through software failure or misuse rather than the software's apparent simplicity.

6. Case Study 5 — Belgium: Own-Brand Labelling Collapse under MDR

6.1 Client Profile

6.2 Project Scope and Duration

Scope covered assessment of MDR exposure across the OBL portfolio, negotiation strategy with legal manufacturers, technical documentation acquisition or reconstruction, and restructuring of the commercial model.

Duration: 21 months. The engagement was substantially commercial and contractual rather than technical, which is characteristic of OBL transitions.

6.3 Product Characteristics

The portfolio comprised four categories, of which the two most exposed are described.

6.4 The Registration Process and Regulatory Strategy

Own-brand labelling — placing a device on the market under one's own name where another entity manufactures it — operated widely under the MDD on a basis that MDR substantially eliminated. Under MDR Article 10 and Article 16(1), a distributor or importer who places a device on the market under its own name assumes the full obligations of a manufacturer, including possession of the technical documentation. Article 16(2) permits relabelling and repackaging without assuming manufacturer obligations, but only within defined limits that do not extend to own-brand marketing.

The manufacturer's MDD OBL certificates had rested on notified body arrangements in which the legal manufacturer's technical documentation supported the OBL certificate without the OBL holder possessing it. That structure is not available under MDR.

The strategic assessment at month one was that the OBL model could not be preserved, and that each product line required one of three resolutions: acquire technical documentation access sufficient to assume manufacturer obligations; revert to distributor status under the legal manufacturer's own brand and CE mark; or exit the line.

Line-by-line resolution proceeded as follows. Of 14 lines, 6 reverted to distribution under the legal manufacturer's brand, 3 secured technical documentation access agreements permitting the client to act as manufacturer, 2 were exited, and 3 — including Lines A and B above — required extended negotiation.

Negotiation leverage analysis. The practice's assessment was that leverage depended almost entirely on the legal manufacturer's own EU market position. Where the legal manufacturer held or sought its own MDR certification and valued the client's distribution reach, documentation access was negotiable. Where the legal manufacturer had no independent EU presence and depended on the client for market access, leverage favoured the client. Where the legal manufacturer was exiting the EU market — the position for Line A's Malaysian manufacturer — the client faced a supplier with no incentive to cooperate and no continuing EU obligations.

6.5 Health Authority and Notified Body Interaction

Notified Body correspondence regarding Line B, where documentation access was secured from the German legal manufacturer, generated 19 findings. The reviewer's principal concern was the adequacy of the client's control over the manufacturing process it did not perform. Possession of technical documentation is necessary but not sufficient; Article 10(9) requires a quality management system covering, among other things, supplier control and process validation. The reviewer required evidence that the client could demonstrate control over design changes, process changes, and supplier qualification at the German site — including audit rights, change notification obligations, and access to process validation records.

The initial documentation access agreement provided document access but not audit rights or change notification. The reviewer assessed this as insufficient.

Line A did not reach conformity assessment. The Malaysian legal manufacturer declined documentation transfer. The client's assessment of reconstruction — generating independent design documentation, biocompatibility data, sterilisation validation, and process validation for a device it did not manufacture — was that cost exceeded €400,000 against annual line revenue of €610,000, with no assurance the legal manufacturer would accept the resulting manufacturing arrangement.

Competent authority interaction with the Federal Agency for Medicines and Health Products concerned the transition status of lines whose MDD certificates were expiring. The authority confirmed that MDD OBL certificates remained valid to their stated expiry under applicable transitional provisions but could not be extended, and that continued placing on the market after expiry without MDR certification would constitute non-compliance.

6.6 Pitfalls and Solutions

Pitfall: the OBL model itself. The originating exposure was structural rather than a discrete error.

Solution. Line-by-line resolution rather than portfolio-wide strategy. The practice's assessment is that OBL holders who sought a single solution for the whole portfolio consistently underperformed those who assessed each line on documentation availability, supplier leverage, and revenue contribution. There is no portfolio-level answer to an OBL transition.

Pitfall: documentation access agreements without control rights.

Solution. The Line B agreement was renegotiated to include annual audit rights at the manufacturing site, mandatory change notification with defined lead time, access to process validation and batch records, and a defined escalation path. This took five months and was achievable only because the German legal manufacturer valued the distribution relationship. The practice's standing advice is that documentation access agreements should be drafted to Article 10(9) requirements — control, not merely access — and that agreements drafted by commercial teams without regulatory input consistently omit audit and change notification provisions.

Pitfall: reconstruction cost misjudged as a technical question. The client's initial instinct on Line A was to assess reconstruction as a documentation exercise.

Solution. Reconstruction was assessed as requiring not only documentation but a manufacturing arrangement the legal manufacturer would accept, a qualified supply chain, and assumption of product liability for a device the client did not design. On that basis Line A was exited and the revenue written off. The practice's assessment is that exiting a line is frequently the correct answer in OBL transitions and is under-selected because it is perceived as failure rather than as capital reallocation.

Pitfall: transitional deadline pressure driving poor negotiation. Two lines were negotiated under expiring MDD certificates, which materially weakened the client's position.

Solution. For the remaining portfolio, negotiations were initiated a minimum of 18 months before certificate expiry. Leverage in documentation access negotiation is a function of time remaining; a counterparty who knows the client's certificate expires in four months negotiates differently from one facing an 18-month horizon.

7. Cross-Case Observations

7.1 Comparative Summary

7.2 Recurring Patterns

The binding constraint is frequently external to the manufacturer. In three of five cases — the medicines authority queue, reference laboratory capacity, and the expert panel timeline — the critical path ran through a body the manufacturer could not schedule. Engagements that identified this early and scheduled productive parallel work performed materially better than those that treated external queues as waiting periods.

Documentation format matters as much as content. Case 1's CTD restructuring and Case 2's source data traceability findings both concerned presentation rather than underlying substance. Assessors read within conventions, and submissions that violate those conventions generate query rounds regardless of technical merit.

Portfolio rationalisation and line exit are under-selected. Cases 3 and 5 both resolved substantially through discontinuation. In both, the manufacturer initially resisted discontinuation as failure. In both, it was the decision that made the remainder deliverable.

Contractual position determines regulatory position. Case 1's API supply agreement, Case 5's documentation access agreements, and Case 3's absence of any supplier framework all illustrate that MDR obligations frequently cannot be met without contractual rights the manufacturer did not secure. Regulatory review of supply and licensing agreements before they are executed is materially cheaper than renegotiation under deadline.

Narrowing scope accelerates certification. Case 4's indication narrowing, Case 2's specification reformulation, and Case 3's grouping strategy all traded breadth for speed. Post-certification change management exists to restore breadth once evidence supports it.

8. Conclusion

These five engagements span member states, classes, and frameworks, and share little at the technical level. What they share is the location of difficulty. In none of the five was the binding problem the manufacturer's engineering, the device's safety, or the quality of the underlying science. The problems were procedural machinery the manufacturer had not identified — a mandatory medicinal consultation, a reference laboratory queue, a classification rule change, an expert panel referral, a statutory transfer of manufacturer obligations — combined, in every case, with contractual or organisational positions taken years earlier for reasons unrelated to regulation.

The practical implication for regulatory affairs practice is that the highest-value work occurs before the technical file exists: classification stress-testing, identification of mandatory consultation and verification steps, mapping of external bodies on the critical path, and review of supply and licensing agreements against the obligations the manufacturer will assume. Engagements that front-loaded this work resolved within their planned envelopes. Engagements that began with dossier assembly did not.

Disclaimer

The information in this article is provided for general informational and educational purposes and does not constitute legal, regulatory, or professional advice. Manufacturer and partner practice identities are withheld under engagement confidentiality, and product descriptions have been generalised. EU MDR, IVDR, and associated guidance are subject to ongoing amendment. Manufacturers should consult qualified regulatory affairs professionals, their designated Notified Body, and the relevant competent authorities for device-specific guidance.