What MDR really means
What used to be MDD — a framework with relative flexibility — is now a regulation demanding substantial clinical evidence, deep Notified Body involvement and continuous post-market surveillance.
MDR applies since May 2021. Transition windows are closing. To be on the EU market in two years, the Notified Body conversation starts today — the market has tightened, waiting lists of 12 to 24 months are the norm.
Classification and documentation
Annex VIII classification is the single most important regulatory decision. Four classes: I, IIa, IIb, III. Class drives the conformity assessment route and therefore timeline and budget.
Class I allows self-declaration — with exceptions for measurement function (Im), sterile-supplied (Is) and reusable surgical instruments (Ir). For IIa, IIb and III a Notified Body is mandatory. Class III requires substantial clinical evidence via clinical investigation or literature analysis.
The Annex II technical documentation: full product description, design basis, manufacturing information, ISO 14971 risk analysis, V&V, clinical evaluation.
Post-market surveillance
PMS under MDR is not an annex — it is an integral part of the conformity system. The PMS plan defines how clinical data is gathered post-market. The PSUR consolidates it periodically. Both are mandatory documents.
ISO 14971 risk analysis is not a checklist. It is a systematic method to identify, evaluate and reduce risks across the full spectrum of possible hazards — with evidence that every risk is reduced to an acceptable level.
Switzerland
For Switzerland, Swissmedic is the counterpart. The MDR chapter of the MRA is in scope — but its operational status requires case-by-case clarification. Serving both markets means running two parallel processes with two authorities.
Case: MDR transition, 18 months off-market
A German SME makes Class IIa diagnostic devices. MDD certificate issued 2019, valid through 2024. In 2022 their Notified Body announces it is exiting medical devices. The MDR transition window is running out. A new Notified Body: 16 months waiting time for review start.
From January 2024 the company cannot deliver new products to the EU. Stocks deplete. Customers switch to competitors. 18 months after MDD expiry, the MDR certificate arrives — market share is gone.
What would have helped: Notified Body search from 2021. The 16-month window could have been bridged with an early start.