Back in November, MAGI’s Clinical Research Conference came to the Fairmont Hotel in San Francisco, California. Considering the wealth of insight on the agenda related to clinical trial technology, regulatory issues, and more, as well as the conference’s convenient location – Medrio’s headquarters is just about a mile down the street from the Fairmont – the decision to attend was an easy one. We met a lot of clinical research professionals doing fascinating things in the industry, and attended plenty of enlightening sessions. In one of those sessions, regulatory experts Kenneth Kleinhenz and Plamena Entcheva-Dimitrov outlined some of the regulatory changes on the horizon for the medical device industry.
As an eClinical software company, one of the most important things Medrio can do is stay alert to the regulatory landscape that affects our industry. Here are some of our key takeaways from that session.
1. Higher standards in Europe
From GDPR and beyond, European clinical researchers are preparing for a far-reaching shift in regulatory paradigms – and medical device research is very much a part of this. The presenters pointed to the new medical device regulation coming in 2020, which will include an upcoming clinical evaluation requirement for certain Class III and Class IIb medical devices, noting that this added requirement could extend the time needed for such devices to arrive to market. Other changes pertain to rules 19 – 22 of the new regulation. And in another significant change, aesthetic devices will now be classified as medical devices and subject to the requirement of a CE mark.
2. Some helpful regulatory clarity
The regulatory changes on the horizon for medical devices don’t simply create additional burdens for device researchers. The presenters noted that the new regulation in fact added some helpful clarification to the rules governing their research. In vitro diagnostic devices, for instance, will be able to gain approval with clinical evidence instead of a full clinical trial. And Class A devices will be able to self-certify instead of answering to a certified body.
3. A shift in geographic favorability
As is often the case in the clinical research industry at large, the evolving regulatory landscape for device trials is having an impact on where these trials take place. Places like Germany, Brazil, and Eastern Europe have seen a decline in favorability as a destination for device research, owing, according to the presenters, to factors such as substantial regulation and a saturation of new applications. This has paved the way for a resurgence in early device trials in the United States – a shift also driven by the 2013 FDA Guidance, which includes such appealing provisions as early patient access to devices.
These are just a handful of the numerous updates provided at this session, which was just one of many enlightening sessions at MAGI’s Clinical Research Conference. All the Medrio staff who were present at the conference had a great time, and we hope for the chance to attend one of MAGI’s future events.