EU Medical Device Regulation (MDR) 2017/745
The new Medical Device Regulation will enter into force after a four-year transition period ending on May 25, 2021.
The European Union (EU) is introducing the new Medical Devices Regulation (MDR) 2017/745 and In Vitro Diagnostics Regulation (IVDR) 2017/746, to meet the constantly evolving technological and scientific progress requirements for medical devices.
Replacing the previous directives, the Medical Device, Active Implantable and In-Vitro Diagnostic Directives (MDD (93/42/ECC), AIMDD (90/385/EEC), and IVDD (98/79/EC) in a complete overhaul of the legal regulations for medical devices.
Transition Provisions Timeline
From the 1st January 2021, under The Medical Devices Regulations 2002 (SI 2002 No 618, as amended) and in line with the MHRA guidance, medical devices placed on the market in the UK must be registered with the MHRA, following a grace period for products not currently required to be registered with the MHRA, depending on the risk classification of the device:
- Deadline of 30 April 2021: Class III, Class IIb implantables, active implantable medical devices, and IVD List A
- Deadline of 31 August 2021: Other Class IIb and all Class IIa
- Deadline of 31 December 2021: Class I devices and general IVDs
The UK MDR requires all devices to be registered, whereas currently only limited classes of medical devices are required to register.
In the United States, medical devices must meet Food and Drug Administration (FDA) standards. IEC 60601-1-2 fourth edition has significant changes that impact both testing and risk management related to basic safety and essential performance.
How manufacturers can prepare for the transition to MDR
Manufacturers of medical devices need to prepare for the new requirements, reassessing their products now to make sure they are compliant by May 25, 2021:
- Check the requirements of the MDR and have a thorough understanding of the new legislation.
- Thorough gap assessments conduct a review of your current products against the new legislation. Gap assessments should consider the reclassification of certain product groups as well as MDR’s wider definition of a medical device.
More guidance on how manufacturers can prepare for the new regulations for medical devices can be viewed here.
We have many years’ experience of accredited EMC testing of medical electrical equipment to EN 60601-1-2. For more information about our EMC testing for medical devices, or to request a quote, contact us today.