CMC


Significant points on how to comp


If you are manufacturing a medical device, you will need to make sure that your products meet the following requirements according to Medicines and Healthcare products Regulatory Agency:

  • the device need to be classified according to the new risk classification criteria (Annex VIII of the MDR and IVDR)
  • meet general safety and performance requirements (Annex I of the MDR and IVDR)
  • clinical evidence should meet the new requirements (Annex XIV of the MDR and IVDR)
  • manufacturers need to have a person responsible for regulatory compliance in place (Article 15 of the MDR and IVDR)
  • economic operators in the supply chain need to be complaint
  • enough financial coverage to be in place (Article 10 of the MDR and IVDR)
  • meet the new vigilance reporting timescales and an annual periodic safety update report is created (Chapter VII, Section 1 and 2 of the MDR and IVDR)

If you are IDVs manufacturer, you should know these new requirements on the IVDR:

  • 80-90% of IVDs will require a notified body to conduct a conformity assessment
  • manufacturers of IVDs will need to produce more performance evidence, which will need to be updated throughout the life cycle of the device
  • the performance and testing of Class D devices will need to be verified by reference laboratories
  • there will be a new consultation procedure for companion diagnostics

You can visit Article 10 of the MDR and the IVDR to see other new requirements.


Sources: Medical devices: EU regulations for MDR and IVDR, Medicines and Healthcare products Regulatory Agency ​, 29 August 2017​, <https://www.gov.uk/guidance/medical-devices-eu-regulations-for-mdr-and-ivdr​>