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Medical device regulation

EU-derived regulations will come into force this May

New regulations on medical devices will come into force on May 26 this year, following a three-year implementation period.

The EU Regulation on medical devices was published in 2017 but will not be affected by Brexit, having been incorporated into UK law.

Those who manufacture, distribute and supply spectacle frames and lenses will be affected by the new legislation. However, devices compliant with prior regulations which were already on the market may continue to be marketed for four years.

Ann Blackmore has been appointed by the Federation of Manufacturing Opticians (FMO) to attend EU meetings and provide regular summaries. The FMO is also offering advice and guidance via its website.