The new Medical Device Regulation (MDR), which will become United Kingdom law from 26 May 2020 as part of the European Union Withdrawal Act 2019, substantially strengthens the regulatory framework for medical devices and notified bodies and manufacturers are having to make significant changes to meet the enhanced requirements.
The Government recognises the importance of having competent notified bodies in place to ensure continuity of supply of products to the UK market. Therefore, the Medicines and Healthcare products Regulatory Agency (MHRA) has been engaging with UK industry and notified bodies on an ongoing basis to ensure that they are prepared for the implementation of the MDR.
There are also transitional provisions in place which enable existing CE marked devices to remain valid for sale until the date of expiry of that certificate. This means in practice that all devices on the UK market do not require immediate re-certification.
The MHRA will publish further guidance on how we intend to support businesses who may struggle to obtain certification under the MDR and to ensure continuity of supply of medical devices to UK patients.