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Tender description

This questionnaire has been issued by the Medicines and Healthcare Products Regulatory Agency, also referred to as ‘the Agency’) on behalf of the Competent Authorities for Medical Devices (CAMD) project. The CAMD network is an umbrella under which the national competent authorities in the EU, and associated parties to the system (European Free Trade Association (EFTA) and Turkey), work to enhance the level of collaborative work in what is a single market for medical devices. Competent authorities have specific responsibilities for market surveillance and other activity under the terms of the legislation. The governance for the network was changed in 2014 to incorporate an elected executive. The executive was charged with developing better collaboration with the European Commission to improve both strategic planning and the distribution of work across both Commission-led and CAMD-led working groups. The Dalli plan set out 3 challenges: enhance collaborative working; improve market surveillance; and better communication. Subsequently, the CAMD network has initiated 2 Joint Action projects which are designed to help the member states deliver on these commitments, and develop better mechanisms for working together and sharing workload: — The 1st concerns the quality of instructions for use of re-sterilisable surgical instruments and is led by the Austria competent authority. This started in November 2015 and is due to be completed by December 2017. The 2nd concerns market surveillance of medical devices which is more expansive and led by the UK competent authority (Medicines and Healthcare products Regulatory Agency). This, subject to agreement, will run from autumn 2016 to autumn 2019.