With the EU Medical Device Regulation now fully applied across legacy device classes, hospital procurement teams have inherited a new job: telling the difference between vendors who are genuinely MDR-solid and those coasting on transitional grace periods.
Three questions that reveal everything
First, ask for the certificate itself — not a declaration of conformity, the actual notified body certificate with its expiry date and scope. Vendors with nothing to hide send it within a day.
The PMCF question
Second, ask how post-market clinical follow-up data flows back into the device. MDR made PMCF mandatory and continuous; a vendor who cannot describe their loop in two sentences probably does not have one.
Supply-chain signals
Third, ask which of their products did not survive MDR recertification. Every honest vendor discontinued something. A portfolio with zero casualties usually means the hard conversations are still coming — possibly mid-contract.
Our own MDR certificates, PMCF summaries, and discontinued-product list are available in our standard documentation package. We think that should be table stakes for the industry.
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