Diapharm’s Dr Guido Middeler offers medical devices manufacturers a UK representative service.
The move will give companies from the European Union a way to satisfy the new rules for medical devices in the UK, which will require all products to be registered with the MHRA from 1 January 2021. This registration will be open only to companies based in the UK.
“This UK representative service is the logical next step in expanding our portfolio,” says Dr Guido Middeler, who heads the Medical Devices team at Diapharm. “For years, our EU representative service for market entry in the European Union has been a fixed point of contact for the international healthcare industry.”
Diapharm’s knowledge of the market and specialist expertise will also benefit manufacturers of borderline products that want to keep their products on the British market, as the regulatory status of all healthcare products is to be reassessed by the MHRA as part of the registration process. Middeler explains: “A different or dissenting assessment by the MHRA can jeopardise a product’s marketability. Diapharm helps pharmaceutical companies to make a solid case for classification in the desired marketability segment by providing the justification to clear up any borderline issues.”
In addition to providing strategic advice and acting as a UK Authorised Representative, Diapharm will also make it possible for European manufacturers of medical devices and in vitro diagnostics to obtain a conformity assessment from a notified body in the UK. With existing EU certificates set to become invalid in the UK by June 2023, companies will need the support of a responsible person based in Britain after this deadline to be able to apply for the relevant UK certificates.
The UK branch allows Diapharm to take on the role of responsible person for clients within and outside the UK and safeguard the marketability of medical devices for the British market.
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