Regulatory


when applying for the EU quality management system certificate. Manufacturers should consider communicating with their MDR notified body to understand what is required.


Communication is everything If all of the above conditions have been met – congratulations. This is not the end of the challenge though – there is still the question of how to communicate to authorities, payers and customers inside or outside of the European Union that the legacy device product can legitimately benefit from the extended transition time. This can be a challenge, especially since the date on the certificate will show it as being expired, even if that certificate validity has been extended by the MDR amendment. Manufacturers can issue a manufacturer declaration to declare the compliance of their devices and their own organisation with the conditions for the continued marketing of the device. The manufacturer declaration is specific to the MDR amendment and should not be confused with the EC declaration of conformity, which is an entirely different document. A template is available on the European Commission’s website to assist with this process. While many jurisdictions in and outside of the EU seem to be accepting the manufacturer declaration template, manufacturers


and supply chain actors should always be on the lookout for differences – although it is to be hoped that the template available on the European Commission’s website will suffice. For example, the UK has issued their own template to be completed to show compliance with the MDR amendment. For the marketing of legacy devices outside of the EU, a certificate of free sale can also be obtained. There is some confusion over when a letter from the MDR notified body should be sent to authorities, payers and customers inside or outside of the EU. Some authorities may request to see a letter from the MDR notified body as soon as possible. Here, it is important to know that the letter from the notified body confirming a contract under the MDR can only be issued after that contract has been signed. Since the manufacturer and notified body have until September 2024 to sign the contract, it is possible that some notified body confirmation letters will only be available in September or October 2024. Naturally, if a contract is signed at an earlier date (as many contracts already are) then the notified body may issue a confirmation letter at that point. Finally, in principle the notified body letter of confirmation should only need to be issued once. After all, the conditions (signing of the contract covering the applications which have been submitted) are only met once. ●


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