National Competent Authority Expectations for PMS

MDR harmonised the rules — not the practice

EU MDR set a single regulatory framework across all member states. What it did not do is make every national competent authority (NCA) identical in how it applies, monitors, and enforces those rules. If you place devices in multiple EU markets, you are dealing with multiple NCAs — and while the legal basis is the same, the experience of reporting, inspection, and relationship management can vary significantly.

This matters for PMS because vigilance reports go to the NCA in the member state where the incident occurred, not necessarily the member state where you are registered. A manufacturer registered in Germany with an incident in Poland reports to the Polish NCA (Urząd Rejestracji). If you have incidents across six countries, you may be managing six NCA relationships simultaneously. Understanding what each authority expects — in substance, in format, and in timeline — saves a lot of reactive scrambling.

How enforcement culture varies

Some NCAs are primarily reactive: they receive vigilance reports, review them, and follow up if there are questions. Others are more proactive: they conduct market surveillance inspections, request PMS data as part of routine oversight, and compare adverse event rates across manufacturers with similar products. Neither approach is inherently better, but knowing which type you're dealing with shapes how you should prepare.

Germany's BfArM and France's ANSM tend to be more active in post-market surveillance oversight and have stronger traditions of market surveillance inspections. The Netherlands' IGJ has historically been active in coordinated EU market surveillance actions through CAMD. Smaller member states often have limited NCA staff and may process vigilance reports more slowly, but may also be quicker to escalate to SCENIHR or CAMD if they identify a cross-border issue.

One practical consequence: if an incident occurs in a member state with an active NCA, you can expect follow-up questions within the standard timeframes. If it occurs in a member state with a smaller authority, you might not hear back quickly — but silence doesn't mean the report was accepted. It means it's in a queue.

National databases and reporting channels

EUDAMED is intended to become the central EU adverse event reporting system, but full implementation has been delayed. In the interim, most NCAs maintain their own reporting channels — some via online portal, some by email or form submission. The format requirements vary.

A few that matter:

Germany (BfArM): The MARIS system handles vigilance reporting for Germany. BfArM provides detailed guidance on what a serious incident report must contain, and they do follow up. Reports submitted in German are processed more smoothly in practice, even though German is not legally mandatory.

France (ANSM): Reporting goes through the ANSM's dedicated adverse event portal. ANSM is known for detailed follow-up questions and sometimes requests original documentation (clinical records, internal investigation reports) within the reporting timeline.

Czech Republic (SÚKL): The State Institute for Drug Control handles medical device vigilance. The SÚKL portal accepts reports in Czech or English, but the follow-up correspondence tends to be in Czech. If you are selling in the Czech market, having a Czech-speaking contact in your regulatory team is practical rather than optional.

Netherlands (IGJ): Reporting via the IGJ's online portal. The Netherlands is also a coordination hub for multi-country market surveillance — incidents reported to IGJ can be escalated through CAMD to other NCAs if cross-border risk is identified.

Poland (Urząd Rejestracji): Reports in Polish or English. Poland has been increasing its market surveillance activity in recent years and is worth monitoring if you have significant Polish market presence.

What NCAs actually look at during inspections

When an NCA conducts a market surveillance inspection related to PMS, they are typically looking at a small set of things: Is there a PMS plan? Is it current? Does the PSUR or PMSR reflect actual data from the PMS system, or does it look like it was written independently? Are vigilance reports submitted on time? Is there evidence that PMS findings led to any corrective action?

The strongest position in an NCA inspection is being able to trace a complete loop: here is a complaint or adverse event we received, here is how we classified it, here is our investigation, here is the corrective action we took, and here is how that corrective action was verified. If you can demonstrate that loop on two or three real examples, it shows the system is working — not just documented.

One thing that catches manufacturers off guard during NCA inspections: the authority sometimes checks your complaint handling records against your vigilance reports to see if events that should have been reported were not. Inconsistencies between your internal complaint register and your external vigilance reporting history are a significant finding.

Practical recommendations for multi-market manufacturers

Keep a simple contact reference for the NCA in each market where you have a meaningful device presence: authority name, reporting portal URL, key language requirements, and contact for follow-up. This doesn't need to be elaborate — a single page in your regulatory affairs system is enough. When an incident occurs, you shouldn't be searching for where to send the report.

Know the local language requirements at least for follow-up. While reports can generally be submitted in English, NCAs in France, Germany, Czech Republic, and several other member states respond in their national language. Having a regulatory contact who can handle correspondence in those languages — even at a minimum — is a real practical advantage.

Check NCA websites for published guidance. Several NCAs publish national guidance documents that supplement MDCG guidance and reflect their local enforcement priorities. These are not always translated, but reading the headers can tell you what the authority currently emphasises.

Where to go from here

The vigilance reporting resource in this category covers the EU-wide reporting timeline and the EUDAMED reporting structure. The EUDAMED registration by actor resource covers the broader EUDAMED registration landscape. For multi-country PMS management, the most useful external resource is the CAMD guidance documents, which reflect coordinated positions across EU NCAs on PMS oversight.