ENGLISH 21 time, the handling of nanoparticles, the design of software or devices that are “composed of substances”. Anyone who feels that these “exotic device groups” or new requirements are irrelevant to them may be right, and the changes to their own Class I devices are marginal. But it is nonetheless worth taking a deep and detailed look at the legal text, as one might otherwise run the risk of placing non-compliant medical devices on the market (and national law would certainly come into play in this case...). So what’s the best way forward? The right place to start is to take a good look at your own company and role you have decided to play: Are we distributors, importers, authorised representatives or even manufacturers? What do we mean by the word “manufacturer”? Producers and/or holders of marketing authorisation? Or just EU authorised representatives? And what about this OEM/PLM constellation? There is no end of terminology and different meanings – but ultimately only one correct wording. The MDR provides very clear definitions for the different roles and uses them to then derive the associated obligations, so it is best to stick to the official terminology to avoid misunderstandings. And although the devil is in the detail, it is simple in principle: Anyone who develops, produces and places medical devices on the market is classified as a manufacturer, and their obligations are laid down in Article 10 of the MDR. The obligations of distributors, authorised representatives and importers are found in later articles. Furthermore, Article 16 goes as far as to define what a legal person is explicitly NOT allowed to do, as it would otherwise be considered a manufacturer. But things become especially complicated if the processes of device creation are outsourced to service providers or are not performed in-house. This is because anyone who is accustomed to marking required processes as “excluded” based on ISO 13485 may fall into the trap of overlooking that the MDR now explicitly requires this information to be included in the QM system. Aside from the development and delivery of services, this also applies to clinical evaluation, post-market surveillance (incl. PMCF) and attachment of the UDI. The appointment of a Person Responsible for Regulatory Compliance (Art. 15), EUDAMED registration and the preparation and updating of
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