The new EU MDR and IVDR raise a lot of uncertainty for manufacturers. Robyn Meurant, Executive Director, Regulatory Services, IVDs and Medical Devices at NSF International, joined a MedTech panel on May 15 in Paris to discuss the readiness of notified bodies in time for the May 2020/2022 deadlines.
The session Notified Bodies: A Key Pillar of the New EU Regulatory System provided insight into the key challenges notified bodies and the industry are experiencing as the deadlines of the new regulations approach.
The multi-stakeholder panel explored solutions which might be put in place to address these challenges. Moderated by Fabien Roy of Hogan Lovells, the panel also included Lionel Dreux of GMED, Phil Brown of ABHI and Salvatore D'Acunto from the European Commission (EC).
The panel discussed the shortcomings of the new regulatory systems, and Robyn Meurant described NSF’s experience as a potential new notified body. She explained how issues regarding the protracted time to designation, which currently takes around 18 months, and the many grey areas in implementing the regulations, including the need to have a certain number of experts employed, were contributors to NSF’s decision to withdraw from the process.
Lionel discussed the challenges of designation, with the need to have many more staff and have them sufficiently trained as a major obstacle. Phil reported that the impact of Brexit and access to a notified body were major issues for many of its members, especially those that are SMEs.
During the forum, it was evident that the industry, although supportive of the need for good regulation, has grave concerns for the successful implementation of the regulations in the allotted timeframe. There is a strong need for regulators to monitor the potential implications of the more prescriptive and demanding criteria. Calls to action from health science organizations including MedTech Europe urge the EC to accelerate notified body designation to ensure patient safety and continued access to medical devices.
The panel agreed that there are still fundamental issues that need to be addressed with urgency including notified body designation, re-certification of existing products and publication of relevant guidance documents. Failure to implement the new regulations effectively and within the allotted timeframe will jeopardize manufacturers’ ability to keep products on the market beyond the 26 May 2020 and 26 May 2022 deadlines.
It is clear that for manufacturers, advanced preparation and early action are key to ensuring a smooth transition to the new regulations. The new regulations impact the whole medical device industry. Investment in employee training and education of the regulations is vital if manufacturers are to successfully meet the demands of the new regulatory system.
NSF’s EU MDR and IVDR training, which includes eLearning, can help organizations to interpret and plan for the EU regulatory changes, facilitating a much clearer and successful adoption. NSF provides a gap analysis service, helping medical device manufacturers have compliant technical documentation and QMS before submission to a notified body.
Finally, note that the Commission does not believe that the current critical situation regarding notified body designation will be an impediment to full implementation of the regulations. That means that you, the manufacturer, must be ready but time is short. Will you have your products certified by May 2020? If you have doubts, contact NSF now.