Ten Major Changes in the MDR Amendment COM(2025)1023 — A Must-Read for Medical Device Exports

Bottom line: on 16 December 2025, the European Commission issued a major amendment proposal COM(2025)1023 to the MDR (EU 2017/745) and IVDR — the most substantive revision since the MDR was enacted in 2017. The core direction is "substantially reduce enterprises' compliance burden while ensuring safety": certificate validity, product classification, notified body audits and clinical evidence requirements are all being relaxed. Expected to be adopted in summer 2026, with gradual rollout during 2027-2028.

For Chinese enterprises exporting medical devices (especially those doing CE certification) — this is the most important positive regulatory signal in recent years, and possibly the key window for you to re-plan your CE certification strategy.

1. First, clarify: MDD → MDR → amendment, CE for medical devices took three steps

When it comes to CE for medical devices, many people can't tell these terms apart. Let's sort them out:

2. Why is this amendment so important?

Since the MDR was fully implemented in 2021, enterprises, notified bodies and member-state regulators have broadly reported implementation difficulties:

• Certificates are fixed at 5 years per cycle, and the concentrated expiry creates "review congestion"
• Complex classification rules push some products into "upgraded classifications", raising costs
• Excessive clinical evidence requirements weigh heavily on small and medium enterprises (SMEs)
• Notified body audits are long and expensive

COM(2025)1023 responds to all these pain points — overall it's "simplify + relax", which is a major positive for Chinese medical device exporters.

3. Ten core changes (key points)

1️⃣ Certificate validity reform: from fixed 5 years → risk-based periodic review

• Current: the CE certificate is fixed at 5 years; on expiry you must resubmit full certification.
• After the amendment: the fixed 5 years is removed, replaced by periodic review based on product risk class — high-risk (Class III/D) keeps a short strict cycle, low-risk gets an extension.

2️⃣ Classification rule adjustments

• For reusable surgical instruments, active implant accessories, software and more, some products may be down-classified, reducing compliance costs.

3️⃣ Notified body optimization

• Optimize the NB audit process; a separate implementing-regulation draft (Ares(2025)11081575) issued on 2025-12-12 unifies audit time limits.

4️⃣ More flexible clinical evidence

• For mature-technology products (conventional surgical instruments, standardized IVDs), clinical evidence requirements become more flexible, cutting cost and speed significantly. Note: flexible ≠ relaxed; data-quality review will not be reduced.

5️⃣ Simplified PRRC requirements

• Remove the item-by-item qualification requirements at the regulatory level for the "Person Responsible for Regulatory Compliance (PRRC)", instead leaving the enterprise to ensure capability itself.
• SMEs can outsource a part-time/contracted PRRC — no longer required to be full-time.

6️⃣ Simplified repackaging/labelling

• Remove the notified-body certification for repackaging and re-labelling, shifting to direct supervision by member-state competent authorities → simplifies the distribution chain.

7️⃣ Longer PSUR cycle, SSCP exemption

• For some mid-to-low-risk products, the PSUR (Periodic Safety Update Report) cycle is extended from 1-2 years.
• Class IIa implantable devices are exempt from preparing the SSCP (Summary of Safety and Clinical Performance).

8️⃣ International reliance

• Introduce international regulatory reliance; when assessing clinical evidence, NBs may reference review records from the FDA, TGA, PMDA, Health Canada and others → products already approved by other strict regulators get faster CE reviews.

9️⃣ EUDAMED phased release

• The database modules go live in phases (no longer waiting for full completion), with interoperability with national databases required to reduce duplicate data entry.

🔟 UDI SME concessions

• Require UDI issuing entities (GS1, HIBCC, ICCBBA etc.) to provide fee concessions and simplified services to SMEs.

4. Timeline (important)

5. Pitfalls that sink you the moment you hit them (must-read for exporters)

• Don't pause existing compliance work: ⚠️ the amendment is not yet officially in force — don't delay your current CE registration waiting for it. Continue under the current MDR is the iron rule.
• Don't mistake it as "no product needs clinical evidence": ⚠️ flexible ≠ slackening; the review of data quality will not be reduced.
• Ignoring the classification adjustments: ⚠️ companies dealing in surgical instruments/implant accessories/software should analyze whether they benefit from classification downgrades, and plan ahead.
• PRRC employment misconceptions: SMEs can outsource the PRRC, but before the new rule takes effect you must still follow current requirements.
• Skipping EUDAMED registration: phased launch ≠ can be delayed — each module will gradually become mandatory once live, so assign someone to track it.

6. Your 5-step checklist right now

• Continue current compliance: unless the transition period has passed, continue registration under the current MDR/IVDR — don't delay because you're waiting for the new rules.
• Evaluate classification adjustments: judge whether your product benefits from a classification downgrade (surgical instruments, implant accessories, software), and build an internal analysis file.
• Optimize clinical evidence strategy: leverage the Reliance mutual recognition, push multi-market registration in parallel, and maximize compliance returns.
• Restructure compliance staffing: evaluate changing the PRRC from full-time to outsourced/part-time (once the new rule takes effect).
• Watch EUDAMED + the timeline: assign someone to track EUDAMED module launches and the final text of the amendment.

Final thoughts

The EU medical device regulation is moving into a more mature, more pragmatic stage. For Chinese medical device exporters, COM(2025)1023 sends a clear signal — the EU is actively lowering the compliance threshold, but a lower threshold ≠ you don't have to cross it. Companies that understand the changes early and seize the planning window will take the initiative in the next round of the market.

As an export certification consultancy, we work every day helping medical device companies sort out this CE compliance path, complete it, and clear customs smoothly.

If you make medical devices and want to export to the EU, send me your product category and I'll do a free "CE certification compliance assessment" for you — judge which class your product falls into, what route to take, whether the amendment benefits you, and where it's most likely to stall.

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CertFastLine Puhuazhike | Export Certification & Testing & Management Systems Consulting Statement: this article is a compliance reference for general information, not legal advice; COM(2025)1023 is a revision proposal — the final regulation text officially issued by the EU prevails. Because the regulation phases in, specifics depend on your product category and sale timing — we'll keep tracking updates.