THE REVISION OF EUROPEAN LEGISLATION ON MEDICAL DEVICES - The response to the public consultation April 2013 | National Resource for Infection Control (NRIC)

THE REVISION OF EUROPEAN LEGISLATION ON MEDICAL DEVICES - The response to the public consultation April 2013

Consultation
Abstract: 
On 12 November 2012, the Medicines and Healthcare products Regulatory Agency (MHRA) opened a public consultation on the European Commission’s proposals for two new regulations on medical devices and in vitro diagnostic medical devices In the public consultation, the MHRA set out the Government’s view on the changes suggested by the Commission to the current regulatory framework on medical devices. We then asked for comments on the Government’s draft negotiating position. This included MHRA draft position on: • scope and definitions; • making available of devices, obligations on economic operators, reprocessing, CE marking and free movement; • identification and traceability, summary of safety and performance information; • notified bodies; • classification and conformity assessment; • clinical evaluation and investigations; • vigilance and market surveillance; • cooperation between Member States and EU reference laboratories; • confidentiality, data protection, funding and penalties; and • the final technical provisions of the legislation In this response to the public consultation, MHRA have summarised the main points made by respondents in response to each of the questions posed in the public consultation. This is not a one-off exercise and MHRA want to continue to engage with stakeholders as the negotiations with the European Parliament and the other Member States of the EU progress. It is worth highlighting that the final legislation is subject to negotiations by all countries in the EU and the European Parliament. Therefore the final legislation may differ from the UK’s policy position set out in this document
Authors: 
MHRA
Category: 
Control
Management
Prevention