Compliance
MDR and GDPR: separating the claims from the evidence
A practical reading list for procurement teams before a clinical evaluation.
Healthcare buyers are asked to compare products that use the same words with different scopes. “CE marked”, “MDR ready” and “GDPR compliant” can mean very different things depending on the product, the class and the intended use.
The useful move is to ask for a product-specific claims matrix: which product, which intended use, which class, which evidence and which date. A Trust Center should make that matrix easy to find, not hide it in a sales deck.
We treat our own site the same way. If a claim is not approved for a product, it does not appear. The regulatory status and the certification evidence live together, with a named owner and a review date.