Do standalone devices exist? Medical devices are typically used in a wider therapeutic or diagnostic context. They are often used together or sequentially with other products, often medical devices or medicinal products, and sometimes also other types of products. They may be connected or compatible, they may interface or be used simultaneously. They may use … Read more
Article 59 MDR/Article 54 IVDR Article 59 (1) says: ‘By way of derogation from Article 52 of this Regulation (…), any competent authority may authorise, on a duly justified request, the placing on the market or putting into service within the territory of the Member State concerned, of a specific device for which the applicable … Read more
When things start falling apart… We may all be able to imagine our worst nightmare: when you realize there is something so terribly wrong with your device(s), that this is causing a huge threat to the existence of the company. This can come in multiple shapes, like an announcement by your notified body that the … Read more
Helping your notified body working efficiently We all know that notified bodies are in short supply and they should work as efficient as possible. There is something we can all do to help: prepare documentation well. It sounds obvious, but I still have to explain to companies that notified body reviewers want to see clear, … Read more
Article 16 inconsistencies As you can read in another tip of the week, MDR Article 16 allows for a third party to repackage or relabel a device or to translate the instructions for use and add them to a device already placed on the market. Packaging, labelling and providing user information are typical manufacturer’s responsibilities … Read more
Manufacturer versus importer/distributor The MDR relates specific roles and responsibilities to manufacturers, importers and distributors. Only the manufacturer should therefore make changes to the information provided with the device and the packaging. However, sometimes the importer and/or the distributor make such changes. Article 16 of the MDR/IVDR sets out when such change puts a manufacturer … Read more
Systems and procedure packs In other articles I discussed grouping devices into the Basic UDI-DI, and also the strategic importance of the Basic UDI-DI from a regulatory perspective. This article sets out how UDI is used for the identification of systems and procedure packs. Article 22 defines a system of procedure pack as a combination … Read more
The strategic consequences of specific Basic UDI-DI groupings As can be read elsewhere, a Basic UDI-DI groups devices with the same intended purpose and the same essential design and manufacturing characteristics into device families. Within this context a company can chose to apply various levels of granularity. This freedom should be used with great caution, … Read more
Basic UDI-DI MDCG guidance 2018-1 Rev. 4 starts with: ‘The Basic UDI-DI is the main key in the database and relevant documentation (e.g. certificates, declaration of conformity, technical documentation and summary of safety and clinical performance) to connect devices with same intended purpose, risk class and essential design and manufacturing characteristics.’ In order to help … Read more
Tumbling during implementation What two things have EUDAMED, an app for managing a specific cardiac condition and an injection pen for lay use in common? They had huge issues with the implementation. They are not in (official) use. EUDAMED is being used, but not yet officially applicable. It should have been applicable since May 2020 … Read more