The British Standards Institution (BSI) was informed by the Medicines and Healthcare products Regulatory Agency (MHRA) that its UK notified body is the first in Europe to be designated to the new MDR (EU 2017/745).
This new regulation was published on 5 May 2017 and manufacturers will need to start complying with it by the 26 May 2020 in order to be able to place their devices on the market within the European Economic Area. The challenge, until now, has been that no notified body was approved to undertake conformity assessments under the new, more stringent, legislation. The BSI will now be able to provide conformity assessments to the full scope of the MDR. See the BSI for more information.
Also see the BSI presentation from the MedTech summit, held in Nurnberg, Germany, 21-23 May 2019. EU MDR notified body overview and update.
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