Medical Device Regulation Pro and Contra

Today finally the MDR EU 2017/745 comes into force and it brings many aspects that will help improve the quality of medical devices and the associated data, but on the other side of the coin there are still many things that could be added to support safer medical device development.

The Pros

On the positive side the increased focus on post market surveillance is extremely helpful, increases the emphasis on continuous improvement after the product launch. Ensuring that more attention is given to proactive post market surveillance is an important step to minimise the chance of failures and the corresponding harm.

The up-classification of certain products, in particular software apps is a very positive step as many apps for medical devices are at present not given the appropriate level of scrutiny prior to placing them on the market, this will change for many devices as they move from class I to class IIa.

Unique device identifiers being applied across the continent in the similar fashion to the US is also a very positive step. The traceability not only of devices but also accessories is important in improving the identification of products following any incident.

The Cons

State of the art is still a term used without giving any explanation of what this actually means. As we described in our blog (Are you brave enough to use state of the art?), this term is very open and for many people it is difficult to define exactly what is meant by state of the art. ISO 14971 added the definition of the term in 2019, which does help clarify the position.

Usability or human factors is a key topic in the medical device lifecycle, but is only mentioned twice in the MDR and only in sentences on examples. More emphasis could be placed on the formative nature of evolving products using usability engineering.

Decommissioning of products and in particular the decommissioning of devices containing patient healthcare records would also be a helpful addition.

The complexity of the regulation and the sheer number of certifications required have caused many problems, but these should start to ease as the months go by.

All in all, the MDR is a positive step, adding more rigour to the process of medical device regulation, but there are still areas where enhancement is required, let’s hope that at some point some further improvements will be introduced.

By Alastair Walker, Consultant and Owner