Medical devices cover a wide range of products – from sticking plasters to hip replacements, from contact lenses to personal oxygen tanks and implanted pacemakers. These devices and others like them, can be found in every household across Europe, once they have been CE marked.
To make sure devices like these are acceptably safe and perform as intended, Competent Authorities need to have a strong programme of market surveillance.
On 19 October 2016, at the 39th meeting of the Competent Authorities for Medical Devices in Bratislava, Slovakia, MHRA officially launched the Joint Action on Market Surveillance of Medical Devices.
The project aims to reinforce the market surveillance system for medical devices by improving the coordination of activities by all member states of the European Union, and ensuring adequate communications and cooperation. These are crucial for success and effectiveness of the market surveillance in the field of medical devices.
The Joint Action supports the Consumers, Health, Agriculture and Food Executive Agency’s (Chafea) programme of community action in the field of health to deliver against one of its objectives: to contribute to innovative, efficient and sustainable health systems.
Chafea is entrusted by the European Commission to implement the health programme and EU Members States involved in the programme – in January 2016.
John Wilkinson, MHRA’s Director of Medical Devices, said:
We are pleased to be leading this important activity and look forward to working with our colleagues across the EU in delivering improvements to reinforce market surveillance.
The Joint Action will be implemented through five work packages: MHRA leads on three (Coordination dissemination and evaluation), while two will be implemented and delivered by EU Member State partners: the Netherlands (manufacturers’ inspection) and Ireland (clinical process and resource development).
More information about the Joint Action can be found on the CAMD website
To report a suspected problem or incident with a medical device please visit the Yellow Card Scheme website.
MHRA is responsible for regulating all medicines and medical devices in the UK. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks. MHRA is a centre of the Medicines and Healthcare products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). The Agency is an executive agency of the Department of Health. www.mhra.gov.uk