The AI Act, MDR, and Notified Bodies

Now is not only a busy season in Europe in terms of the uptick in tourism, but it also is turning into a crowded calendar for medical device-related legislative and regulatory changes that product companies need to track in order to get and keep their products on the European market. Most prominent, of course, is the medtech-specific Medical Device Regulation (MDR) and its diagnostics counterpart the In Vitro Diagnostics Regulation (IVDR). Although first enacted in 2017, these regulations have presented numerous challenges that, together with the COVID-19 pandemic, have resulted in several deadline extensions that now reach until near the end of the decade, depending on product risk classification. Today, however, there are increasing calls to stop delaying the process and actually revise the regulations despite their recent vintage. Much hinges on the outcomes of the upcoming EU-wide elections in June.

If MDR and IVDR weren’t enough, device companies are also impacted by several major pieces of horizontal legislation that, while not aimed specifically at medtech, impose additional compliance requirements on many product companies, along with those of a wide range of other industries. The most recently enacted of these is the AI Act, which governs and sets standards for products that employ AI technologies, a category affecting an increasing number of medtech firms. The AI Act comes on the heels of equally wide-ranging recent EU legislation governing data protection and cybersecurity that also impacts certain segments of the medtech community. All in all, this flood of new legislative and regulatory standards combine to form a virtual Venn diagram of new compliance standards that companies need to be aware of and prepared to address.