Intended for healthcare professionals

  1. Chris Allan, public health registrar1,
  2. Thomas J Joyce, professor of orthopaedic engineering2,
  3. Allyson M Pollock, professor of public health1
  1. 1Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK
  2. 2School of Engineering, Newcastle University, UK
  3. Correspondence to: C Allan

Commercial interests and lack of transparency remain key weaknesses

The new EU Medical Devices Regulation ((EU) 2017/745) comes fully into force on 26 May 2020.1 This “fundamental revision” of the existing regulatory framework is intended to “ensure a high level of safety and health whilst supporting innovation,”1 to provide a better guarantee for the safety of medical devices, and to restore the loss of confidence2 that followed high profile scandals around widely used hip, breast,2 and vaginal mesh devices.3

The regulation is implemented through national competent authorities—such as the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK—and the notified bodies designated by them to assess devices’ conformity with regulatory standards. There are four notified bodies in the UK. Conformity assessments are based on the intended purpose and associated risk of a device: if a conformity assessment finds a device to be compliant with the European regulations, the manufacturer can brand …

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