The two new EU regulations on medical devices (Regulation (EU) 2017/745) and in vitro diagnostics (Regulation (EU) 2017/746) rely on the know-how of expert panels to support the safety and efficacy of medical devices on the EU market.
The expert panels will have a broad spectrum of advisory roles to the European Commission, the Medical Device Coordination Group, Member States, Notified Bodies and manufacturers.
A key role for the experts will be to provide an independent opinion to Notified Bodies on the assessment of high-risk devices, before certification. The experts will also be involved in other tasks, such as contributing to the development of common specifications for clinical evaluation of device categories, guidance documents or standards.
Selected experts will be appointed to panels in relevant medical fields, such as cardiovascular devices, orthopaedics, neurology, but also in other areas, such as in vitro diagnostics, for a renewable term of three years. Eligible applicants that are not appointed to an expert panel may be included in a central list of experts available for replacements and temporary assignments to expert panels. The list will remain valid for five years.
Interested candidates are invited to check the conditions, eligibility and selection criteria in the call text. Applications must be submitted before 24 November 2019 by using the dedicated web page, and by including the required supporting documents.
The Joint Research Centre (JRC), together with other European Commission services, actively supports the implementation of the new regulations. The JRC has contributed in particular to activities in the medical device area, such as signal detection and manufacturer's incident reporting.
The JRC also supports various European Commission working groups on specific scientific topics in the area of clinical investigations and vigilance of medical devices. In addition, the JRC explores the status and challenges of converging technologies and innovation in health products, e.g. in the area of cybersecurity.
- Dáta foilsithe
- 7 Samhain 2019