The new European medical device regulation and guidance document on clinical evaluation

An Interview with Dr Bassil Akra

The successor of the currently applicable Medical Device Directives (MDD 93/42/EEC and 90/385/EE) combines both directives into one Medical Device Regulation (MDR).

At the time of the interview, the MDR publication date had been scheduled for the second quarter of 2017. (The MDR has now been published and is accessible at http://eur-lex.europa.eu/eli/reg/ 2017/745/oj). The new MDR adds new requirements to the quality management system of medical device manufacturers, clinical evaluations and post-market surveillance. Moreover, this regulation influences the classification of several devices that are currently on the European market and covers new device categories such as devices for cosmetic purposes and non-viable human tissue. Furthermore, the MEDDEV 2.7/1 Rev 4 guidance document on clinical evaluation of medical devices has been released in June 2016. This revision is more detailed and particularly provides further guidance on the writing and update of clinical evaluation reports. Moreover, this guidance document includes essential details on the type of clinical data that can be used during this process and the responsibilities of the notified bodies.

We are delighted to have the chance of interviewing Dr Bassil Akra, who is a representative of the European Notified Bodies on various clinical task forces and participated in the development of this new guidance document, to gather first-hand information on the matter. He is the Global Director of the Clinical Focus Team at the largest Notified Body, TÜV SÜD Product Service GmbH, and has extensive experience in research, development, quality management and regulatory approval of medical devices, combination devices and Advanced Therapy Medicinal Products (ATMP).

He is a senior expert and internationally renowned speaker on European regulations and a member of the European Clinical Investigation and Evaluation working group. Dr Akra is representing Team NB and NB MED in several European discussions regarding clinical requirements such as MEDDEV and other Guidance Documents on Innovative Devices, as well as a member of the European task force on Safety Update Reporting.