Regulatory Update - April 2021
Due to the nature of our business, Jointmedica has always been regulatory focused, but the recent announcement regarding the transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) has heightened our activities. We spoke to Steve Meakins our RA/QA Manager, on how will these changes affect JointMedica and what steps need to be in place.
“May 2021 is a very important month for the medical device industry as the new Medical Device Regulations (MDR) are implemented in the European Union. The new regulations demand extra requirements of manufacturers and certification bodies with the aim of improving patient safety. JointMedica is working towards MDR compliance in order to fulfil our ambitions for the clinical investigation of the PolymotionTM Hip Resurfacing (PHRTM).
The first step to becoming MDR compliant involves the appointment of a Notified Body designated to issue MDR certification. This is a significant challenge as the number of Notified Bodies has decreased, and the newly designated Notified Bodies strive to implement new processes, manage their existing clients, and cope with the huge demand of new MDR applications.
The regulatory landscape has been further clouded by Brexit, meaning that the UK will not be implementing the MDR. The MHRA has instead implemented UKCA marking requirements for medical devices in the UK based on the existing requirements of the Medical Device Directive (MDD). This involves the establishment of a new UK regulatory structure including UK Approved Bodies, of which there are currently even fewer options than Notified Bodies.
Whilst the PHRTM does not require certification as an investigational device, the planned UK clinical investigation does require the use of certified surgical instruments. Although the UK requires UKCA marking for medical devices, there is the provision for CE marked devices to be accepted until July 2023.
JointMedica has now navigated through the first steps of this regulatory minefield by appointing an MDR designated Notified Body. This will enable JointMedica to CE mark surgical instruments ahead of the PHRTM clinical investigation but will also allow the transition of these instruments to UKCA marked devices after July 2023 as our Notified Body partner completes its UK Approved Body designation. This has the added benefit of ensuring that JointMedica’s surgical instruments will be subject to the more stringent requirements of the MDR giving increased confidence to our surgeons and patients of their safety and effectiveness.
This is just the beginning of JointMedica’s path to MDR compliance, however JointMedica has a dedicated team of professionals realising the challenge for the exciting journey ahead.”