How do we break this to you gently? OK we can't. The blunt answer is no. Starting May 26, 2021 there are some aspects of the European Medical Device Regulation (MDR 2017/745) that apply to ALL device manufacturers – even those holding valid MDD CE Marking certificates that expire as late as 2024. Here’s what you need to know.
Even if you hold a valid Medical Devices Directive (93/42/EEC) certificate that expires in 2024 and even if you don't make any changes to the product whatsoever there are certain aspects of the MDR you must meet going forward from May 26, 2021.
MDR Article 120(3) reiterates that ALL device manufacturers must comply with certain aspects of the EU MDR starting May 26, 2021
There are specific areas of the MDR that apply to all medical devices starting May 26, 2021. The requirements can be found buried toward the end of the MDR in Article 120(3). By the way if you read the original Article 120(3) you are only getting half the story. In late 2019 Europe issued the second official Corrigdenum (amendment) which modified the original Article 120 published in 2017. The new text is below.
“By way of derogation from Article 5 of this Regulation, a device which is a class I device pursuant to Directive 93/42/EEC, for which the declaration of conformity was drawn up prior to 26 May 2020 and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body, or which has a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and that is valid by virtue of paragraph 2 of this Article, may be placed on the market or put into service until 26 May 2024, provided that from 26 May 2020 it continues to comply with either of those Directives, and provided there are no significant changes in the design and intended purpose. However, the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives.”
The devices module of EUDAMED is not yet active so this does not apply for now. The first sentence of MDR Article 120(3) would make it seem as though this requirement only applies to Class I manufacturers holding valid MDD certificates. Wishful thinking. The need to comply in the aforementioned areas applies to all classes of devices.
All medical devices shipped to Europe must be linked to an importer
The role of the importer is not new. It has been specified in Section 3.3 of the European Blue Guide but was not mandatory in the Medical Devices Directive (93/42/EEC). However, Article 13 of the MDR made it crystal clear that the importer plays a key role in compliance for the manufacturer and is, by default, mandatory starting May 26, 2021. The importer does not take physical possession of your devices, but they do have many responsibilities that are similar to your European Authorized Representative.
So what should you do? First, we recommend that you register your company in the new EUDAMED database. It’s not yet required but doing so now will prevent any delays by the time it will become mandatory and will give you a Single Registration Number. After that you will be able to appoint an importer for your devices sold in Europe. If you do not have a legal entity inside the European Union, you have many options here, including asking a distributor to perform this role. There are many perils with this approach and that’s why most companies are finding it best to outsource the importer role to an independent company that specializes in this fulfilling this role. MedEnvoy can assist you in meeting this new MDR importer obligation.