醫療器材冰山：掌握 MDR 2017/745 下的技術文件

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.

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.

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.

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].

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.