New European Union regulations on medical devices (MDR) were laid down on 26.5.2017. It is important to notice that this spring, on the 26th of May 2020, the transition period ends, and medical devices are no longer certified based on the former medical device directive (MDD). For in vitro diagnostic devices the deadline has been extended until 26.5.2022.
The new regulations are intended to clarify, harmonize and simplify the processes governing medical devices, but, at the same time, they broaden the scope medical device definition and tighten the rules of regulation. For example, data and software are more thoroughly assessed in the MDR. Furthermore, all devices for diagnostic purposes require a notified body, i.e. an organisation designated by an EU country, to assess their conformity before they can be released to the market.
The MDR prefers harmonized standards and using these standards while innovating devices for diagnostic purposes will shorten the registration process and enforce cost efficiency. At least check this fancy roadmap to get in terms with the new regulations and tips for standards. Bear in mind that patents on standardized medical device solutions are usually high in value because it will be more difficult to introduce alternative solutions or design around a standard-obeying patent in the heavily controlled medical technology environment.
MedTech special interest group in Berggren Oy forms a collective of professionals from different fields of expertise to help you overcome the challenges related to immaterial rights in the fields of medical and health technology. Should you want to discuss any issues related to intellectual property rights, related to medical and health technology or in general, please do not hesitate to contact our MedTech professionals!
Jarno Mikkonen, jarno.mikkonen@berggren.fi, tel. +358 44 355 3440
Seppo Kilpeläinen, seppo.kilpelainen@berggren.fi, tel. +358 40 588 9852