The forthcoming Medical Device Regulation (MDR) has gained a significant amount of attention in industry publications in recent months. The question is, how will it support design teams in ensuring they develop safe medical devices?
The good news is that many of the clauses in the MDR help add clarity to the process.
Risk management and how it supports ISO 14971 has been well documented in Annex 1, GENERAL SAFETY AND PERFORMANCE REQUIREMENTS, with good use of the term State of the Art when talking about Risk Control Measures.
When looking for the links from the MDR to IEC 62304 or IEC 82304, there are clear guidelines not only on the definition of software requirements, but more importantly guidelines on software taking the same classification as the device it is operated on in ANNEX VIII, Classification Rules.
Annex I section 17 also creates a good link between the MDR and IEC 60601-1 Programmable Electrical Medical Systems (PEMS) and how teams can consider single fault safe implementations. Security is also a topic in Annex I.
Unique Device Identifier (UDI) has been a popular topic over the last few years, but the Medical Device Regulation helps add clarity on how it should be structured in software.
Active devices, i.e. dependent on an energy source, are well documented in the MDR and the fact that software shall be an active device also.
For experienced design teams in the medical device sector there should be no great surprises in the MDR. However, for teams new to the medical device sector there is a far better linkage between the EU regulations and the standards that are likely to be used by the teams, which is always one of the trickier activities when navigating the regulatory landscape.
We are looking forward to the wide spread implementation of the MDR as it adds benefit and supports safer development in the medical device domain.