The Future of Medical Device Regulation

by | Oct 25, 2021 | Blog, Medical Devices

The Future of Medical Device Regulation in the UK – Do you know that the regulatory framework for the manufacture and supply of medical devices in the UK is changing?

The MHRA is running a consultation, with both members of the public and industry, to help shape their future approach to regulating the Future of Medical Device Regulation in the UK.

They want to develop a future regime for medical devices which enables:

  • Improved patient and public safety;
  • Greater transparency of regulatory decision making and medical device information;
  • Close alignment with international best practice, and;
  • More flexible, responsive and proportionate regulation of medical devices.

The consultation runs until the 25th of November. The MHRA have included a video of their recent Industry webinar on how to submit your views here:

https://www.gov.uk/government/consultations/consultation-on-the-future-regulation-of-medical-devices-in-the-united-kingdom?utm_medium=email&utm_campaign=govuk-notifications&utm_source=cb4e8bbf-8520-44e9-86d1-56c33a82e1cc&utm_content=daily

A link to the consultation documents itself can be found here:

https://www.surveys.mhra.gov.uk/613cff3142a2b02700706bad

The supply of Medical Devices is not part of the scope of a WDA(H) licence, however many suppliers use the same quality systems to manage devices supply as used for the supply of medicines. If you require any help or guidance with the quality management of your medical device supply chain please contact us on 01252 375362 or through our contact us page.

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