The MDR (EU Regulations for medical devices) has rightly been the subject of much attention in recent months as the date of application approaches in May this year. There has been a slow but steady stream of Notified Bodies receiving their designation and although still falling short of what has been historically available under the MDD there are finally signs that capacity might start to catch-up in the medium term.
In the same way that well prepared medical device manufacturers started planning for transition several years ago, the same should be encouraged for manufacturers of In-Vitro Diagnostic (IVD) devices. Arguably this sector of the medical market faces an even more significant challenge over the next couple of years. Changes in the IVDR mean that the majority of manufacturers will be required to undergo notified body audit with increased scrutiny of their technical file, design documentation, risk management process and clinical data. For a part of the industry where self-certification has been the norm, this represents a significant change.
At eg technology, we are ensuring our engineers and project managers are all trained on the requirements of the IVDR. To provide the best possible service to our clients that means not only understanding our role in producing design and technical documentation, participating in risk management, and working to harmonised standards, but also ensuring our team have a good, broad understanding of all of the new requirements so that we can support our clients as they build their product roadmap. With the conformity assessment process for IVDs in Class B and above including review based on a quality management system, we are continuing to build links with regulatory partners to ensure that if we can’t help, then we know someone who can.
As I write this, there are only three notified bodies designated to IVDR in the Nando database. Other notified bodies are in the process of seeking designation and doubtless (much the same as MDR) there will be a ‘flurry’ of new organisations achieving designation just before the date of application in 2022, but this could still be too little, too late for unprepared IVD manufacturers.
Companies who start now or have already started to plan their IVDR strategy already will have a significant advantage in securing access to a notified body, ensuring they can continue to sell under the new regulations. As with the MDR, manufacturers need to make careful decisions regarding their IVD product portfolio:
- Conduct an honest internal audit and gap analysis of existing technical files and begin work to bring products into line with IVDR
- Continue sales based on existing approvals before the final cut-off date of 2027 (then potentially drop the product)
- Design new products to meet IVDR requirements
As medical device manufacturers have already found, increased scrutiny by notified bodies means increased scrutiny of clinical data, therefore for products already on the market or near to market any plan for compliance with the IVDR also needs to include a strategy for gathering clinical performance data.
Contact us for more information on how eg technology can support your IVD device development.