Regulatory Focus™ > News Articles > UK Opens Consultation on Proposed EU Device Legislation

UK Opens Consultation on Proposed EU Device Legislation

Posted 13 November 2012 | By Louise Zornoza 

The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) opened a public consultation on 12 November 2012 on the European Commission's proposals for three new medical device regulations set to replace existing EU directives.

The proposals-two on medical devices and one on in vitro diagnostic devices (IVDs)-are still in draft form, and MHRA said it was urging industry and the public to comment on them before they become final. The proposals are a direct result of safety concerns following the failure of regulators to protect the public from faulty medical devices in the last few years, MHRA noted.

MHRA said it engaged with the Commission to influence its proposals as they were developed over the last four years, but remained concerned with three provisions under consideration that it said could place additional burdens on industry and the healthcare system without providing any benefit to public health.

The MHRA consultation document details the specific provisions in the proposed device legislation and provides its views on the provisions. For example, the agency opposes exclusion of certain IVDs from the proposed 'in-house' exemption, which would in its opinion result in some tests no longer being available to be used by the National Health Service (NHS) because there are currently no CE-marked tests available for many genetic conditions and rare diseases.

The MHRA requests interested parties to answer the questions that it poses concerning the agency's views on specific provisions in the proposals, as well as providing recommendations on how the legislation could be improved.


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