The following key areas have been identified by the subcommittee for further investigation: 

· Concern about lack of regulation of energy-based devices intended for cosmetic use

· The role of the MHRA in providing vigilance and oversight for medical devices in the UK

· Concern about variability of training and support offered by medical device suppliers

· Possible new technologies and how these should be captured under new or existing legislation

As a result of this Group’s work the attached paper sets out the regulatory requirements for medical devices in the EU (CE marked under the relevant medical devices legislation) and the current situation in the UK post-Brexit (including requirements around UKCA marking in Great Britain). Consideration is given to the new regulation in EU, which has brought into scope of medical device regulation, certain products for which a manufacturer claims only an aesthetic or another non-medical purpose, but which are similar to medical devices in terms of their functioning and risk profile.  The EU Medical Devices Regulation applies in Northern Ireland, but not in Great Britain.  With respect to domestic requirements for the regulation of the above products, it is recommended that the JCCP await the outcome of a recent MHRA consultation on the future regulation of medical devices in the United Kingdom (Consultation on the future regulation of medical devices in the United Kingdom - GOV.UK (www.gov.uk)).

To read the article click here