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July 17, 2025

Approximately 5 minutes

Master Technical Documentation under MDR 2017/745

Mastering Technical Documentation under MDR 2017/745

In the world of medical device registration, your technical documentation (TD) isn't just surface work. It is the hidden foundation that Notified Bodies examine first. Under MDR 2017/745, your TD serves as your device’s identity card, proving it meets rigorous safety and performance standards.

The 7 Essential Pillars of Technical Documentation

Your TD should not be a collection of loose files but a structured, coherent, and evolving system guided by Annex II and III of the MDR. It rests on seven critical pillars:

  1. Device Description & Specification: Defining what the device is and its variants.
  2. Information Supplied by Manufacturer: Labels, packaging, and Instructions for Use (IFU).
  3. Design & Manufacturing Information: Blueprints and the processes used to build the device.
  4. GSPR (General Safety & Performance Requirements): The checklist proving compliance with Annex I.
  5. Benefit-Risk Analysis & Risk Management: Systematic management throughout the product lifecycle.
  6. Product Verification & Validation (V&V): Including bench testing and clinical evaluation.
  7. Post-Market Surveillance (PMS): Plans for monitoring the device once it is in use.

Mastering the 3Cs: Clarity, Consistency, and Connectivity

To avoid infinite feedback loops with reviewers, your documentation must adhere to the 3C principle:

  • Clarity: Write for the reviewer. Use simple, precise summaries and one-sheet conclusions for complex risk or clinical data.
  • Consistency: Use a single intended purpose across every document. Use the same terminology and logic throughout.
  • Connectivity: Cross-reference documents clearly. A change in design impacts risk, which impacts clinical data—trace these connections.

Best Practices for Compilation

  • Create a V&V Matrix: Maintain clear traceability from User Requirements (URS) to Functional Requirements (FRS).
  • Use Searchable Formats: Ensure digital files are indexed and hyperlinked for easy navigation.
  • Summary Documents: Provide reviewers with a high-level roadmap of your TD structure.
  • Regular Updates: Treat your TD as a living ecosystem, not a one-time project.

Get Started with Templates

You don't have to start from scratch. Use these specialized templates to build a compliant structure:

Clear documentation equals faster reviews and a faster path to helping patients.

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Questions & Answers (5)

A
Guest

We produce standard surgical instruments that have been on the market for 20 years. Do we still need to conduct new clinical investigations for MDR or can we use "Well-Established Technology" (WET) exemptions?

ElendiLabs

The MDR is much stricter regarding clinical data. While Article 61(10) allows for some flexibility for devices where clinical data is not deemed appropriate, the "WET" exemption is generally reserved for very specific, low-risk devices (e.g., sutures, staples, dental fillings). For most instruments, you will need a robust Clinical Evaluation Report (CER) that includes a systematic literature review and post-market clinical follow-up (PMCF) data, even if a new clinical trial isn't required.

A
Guest

We manufacture non-corrective "proliferative" (aesthetic/colored) contact lenses. Since these have no medical purpose do we still need to follow the full EU MDR process and what are the "Common Specifications"?

ElendiLabs

Yes. Under Annex XVI of the MDR, products without an intended medical purpose (like aesthetic lenses) are now regulated as medical devices. You must comply with the General Safety and Performance Requirements (GSPR) and specific Common Specifications (CS) outlined in Commission Implementing Regulation (EU) 2022/2346. This includes stricter clinical evaluation requirements than the old MDD—you cannot simply rely on "equivalence" to existing products; you must demonstrate safety based on specific CS criteria.

A
Guest

We are a US-based manufacturer with no physical office in Europe. Can our EU Authorized Representative (EC REP) also act as our PRRC (Person Responsible for Regulatory Compliance)?

ElendiLabs

No. Under MDR Article 15, the PRRC and the EC REP must be distinct roles to ensure a "four-eyes" principle of oversight. While your EC REP must have their own PRRC, you (as the manufacturer) must also appoint your own PRRC. For non-EU manufacturers, the PRRC does not necessarily have to be located in the EU, but they must be "at your disposal" and meet specific qualification requirements regarding professional certifications or years of regulatory experience.

A
Guest

Our diagnostic AI software was classified as Class I under the old MDD. Does Rule 11 of the MDR automatically push us into Class IIa or higher and does this require a Notified Body?

ElendiLabs

In most cases, yes. Rule 11 has significantly raised the bar for Software as a Medical Device (SaMD). If your software is intended to provide information used to take decisions with diagnosis or therapeutic purposes, it is at least Class IIa. Because Class I (self-declared) is now very rare for software, you will almost certainly need to engage a Notified Body to audit your Quality Management System (ISO 13485) and Technical Documentation. We have experts that specialize in Rule 11 gap analysis for AI startups. [Inquire about a Gap Audit].

A
Guest

We are selling a Class IIb device under a valid MDD certificate until 2027. If we update our software's UI or change a minor raw material supplier does that count as a "significant change" that voids our legacy status?

ElendiLabs

This is a critical distinction. Under MDCG 2020-3, "significant changes" in design or intended purpose require you to move to full MDR compliance immediately. A UI update that changes how data is interpreted might be "significant," whereas a minor supplier change for a non-critical component might not. We recommend a formal Significant Change Assessment before making any modifications to ensure you don't accidentally lose your MDD transition period.

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