Posted 29 August 2017
By Zachary Brennan
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday released an introductory guide to help medical device manufacturers understand their obligations under the new EU regulations for medical devices (MDR) and in vitro diagnostic devices (IVDR).
With the three- (for MDR) and five-year (IVDR) transition periods now underway, the new regulations will apply across EU member states from 26 May 2020 and 2022, respectively.
During the transition period, MHRA notes that devices can be placed on the market under the current EU directives or the new regulations, if they comply.
Devices and IVDs marketed after the transition period will need to fully comply, unless they wish to make use of the extended period of CE certificate validity.
Some of the recommendations for companies made by MHRA include ensuring:
- a device has been correctly classified against the new risk classification criteria (Annex VIII of the MDR and IVDR)
- general safety and performance requirements are met, including for labeling, technical documentation and quality management systems (Annex I of the MDR and IVDR)
- increased requirements for clinical evidence are met (Annex XIV of the MDR and IVDR)
- a person is responsible for regulatory compliance (Article 15 of the MDR and IVDR)
- supply chain economic operators are compliant
- sufficient financial coverage is in place for potential liability (Article 10 of the MDR and IVDR)
- the new vigilance reporting timescales are met and that an annual periodic safety update report is created (Chapter VII, Section 1 and 2 of the MDR and IVDR)
On the IVD end, MHRA also notes that changes to classification rules will mean that 80% to 90% of IVDs will require a notified body to conduct a conformity assessment. And manufacturers of IVDs will be required to provide more performance evidence, which will need to be updated throughout the life cycle of the device.
For more information on preparing for the new regulations, see the RAPS MDR, IVDR Explainer or RAPS executive director Paul Brooks’ take on 6 Things You Need to Do to Prepare for the New EU Medical Devices Regulation.
MHRA Guidance: Medical devices: EU regulations for MDR and IVDR