The representatives of the Competent Authorities for Medical Devices (CAMD) met in Bratislava as part of the programme of EU Presidency meetings currently hosted by Slovakia.
From 17 – 19 October 2016, the State Institute for Drug Control hosted the 39th meeting of the Competent Authorities for Medical Devices. During the two days, more than 70 delegates discussed important issues relating to medical devices, including the implementation of the pending new Medical Devices and In Vitro Diagnostic Regulations.
The meeting was held in the Austria Trend Hotel located in the centre of Bratislava. Before the official start of the conference, delegates met at an informal welcome buffet for a short time.
The official plenary session was opened by Marek Slavik, a Slovak Member of CAMD and Head of Medical Devices Section at SUKL, and Zuzana Batova, Executive Director of SUKL. Both warmly welcomed participants and wished them successful and fruitful work in the following two days.
The agenda of the meeting was centred on the emerging regulatory framework: exploring the current issues, challenges and scope for implementation, including those relating to the management of notified bodies. The group was also updated on the progress made by the Joint Action led by Austria (Instructions for use for re-useable and re-sterilisable medical devices), and the launch of a new Joint Action focused on market surveillance of medical devices and led by the UK.
Key issues from the following working groups were also discussed: Compliance and Enforcement Group (COEN), Notified Body Operations Group (NBOG), New and Emerging Technologies (NET), and International Medical Devices Regulators Forum (IMDRF). The Slovak representatives informed their European colleagues about the system used in the Slovak Republic for areas of medical devices registration, vigilance, market surveillance and notified bodies.
Participants also discussed the important issue of the management of situations resulting from the ceasing of activity of some Notified Bodies and agreed on general principles to ensure a consistent approach across the CAMD network.
During workshop sessions, 5-6 implementation challenges were identified and prioritised in the following seven „clusters“:
- Notified Bodies
- Market Surveillance
- Post-Market Surveillance & Vigilance
- Clinical Evaluation (including investigation)
- Classifications & Scope
- Registrations, UDI & Eudamed
- IVD-specific issues
John Wilkinson, Chair of CAMD Executive Group, said “The MDR and IVDR will have wide-ranging benefits for patients across the EU. There is great talent and capability across the CAMD network and I’m optimistic that through clear communication and collaboration, we can successfully support the efficient implementation of the Regulations. The meeting, organised by our Slovak colleagues, has been a major milestone in the development of our plans”.
In addition, the new CAMD website (http://www.camd-europe.eu/) was introduced to members of the network as a tool to support information sharing and collaboration.
The Competent Authorities for Medical Devices (CAMD) is a network of the competent authorities responsible for the regulation of Medical Devices, Active Implantable Medical Devices and In Vitro Diagnostic Medical Devices for human use. The meeting involves the representatives from the national competent authorities from EU, EEA and candidate countries, with the participation of the European Commission. The CAMD acts as a forum to improve cooperation among national authorities, to discuss the state of affairs and to anticipate on the future legislation.