Are you ready to address the risks of the MDR and IVDR?


While the MDR takes effect in May 2020 and the IVDR in May 2022, the changes they require in device development, manufacturing and distribution are significant. Adjusting will take time and effort, so start now.

New certification, clinical evidence and notified body rules may require major changes

The new European Union Medical Devices Regulation (MDR) and In-Vitro Diagnostic Medical Devices Regulation (IVDR) create new risks for device developers. Changes that will directly affect registration of new devices and re-registration of existing ones include sweeping new clinical data reporting requirements, and changes in the roles and scope of authority of the Notified Bodies (NBs) that certify your devices.

Complying with the MDR and IVDR will require changes that touch every stage of the device lifecycle – from product development and clinical testing; to manufacturing, quality assurance and distribution; to post-market clinical performance monitoring and reporting. Adjusting will take time and effort, and must be done to keep medical devices on the European market past May 2020, and in-vitro diagnostics (IVD) past May 2022. Here are how several upcoming changes will affect device manufacturers, and what you can do to prepare:

Reclassification of some medical devices – The MDR reclassifies many devices to higher risk categories. These include surgical meshes and most implantable products that contact the spinal column. The MDR also extends the definition of medical devices to include sterilisation equipment, devices that support conception and cosmetic devices not previously covered. These include cosmetic contact lenses, as well as substances that surgically change anatomy such as collagen implants or injections, and electromagnetic devices for skin treatment, tattoo removal and brain stimulation. 

Impact: Many devices that did not previously require certification must now be certified. Moreover, many devices must now be certified in higher risk categories. Meeting these new, or more stringent, certification requirements will take months, if not years, as well as significant investment and expert resources.

How to prepare: Assess portfolio to determine which products must be certified under which risk categories, and develop a certification plan that includes costs, timelines and expert resources required. Consider whether the additional costs are sustainable product by product and adjust portfolio accordingly.

Certification required for up to 90 percent of IVDs – The IVDR dramatically broadens the definition of IVDs and introduces a new risk-based classification system, which means that up to 90 percent of IVDs will require NB review, up from about 10 percent currently. IVDR also introduces a risk-based classification system that determines the level of review required.

Impact: Many IVD manufacturers will have to add certification processes and infrastructure not previously required, and find NBs qualified to certify IVDs. Doing so will require major investments in new processes and expert resources – and could even require a complete revamp of how IVD devices are developed, tested, manufactured and distributed. This could take months or years and will require potentially scarce resources, notably NB resources that do not currently exist.

How to prepare: Evaluate portfolio to determine which products must be certified under which risk categories. Assess current operations and what changes would be required to comply with new regulation. Develop a certification and operational plan that includes costs, timelines and expert resources required. Consider whether the costs involved are sustainable and adjust portfolios and strategies accordingly. Start talking with NBs about developing the required certification expertise.

Increased data reporting – The MDR and IVDR require clinical evidence to certify or recertify many medical and IVD devices, and post-market clinical follow up and/or surveillance for most devices. Demonstrating equivalence with previous devices will become much more difficult.

Impact: Manufacturers will have to develop clinical evidence packages for certification and recertification of most devices, and set up post-market surveillance and reporting systems. This may take months or years and require significant ongoing investment.

How to prepare: Assess what clinical data are required for which devices and develop a plan that includes costs, timelines and resources required. Consider whether the additional costs are sustainable product by product and adjust portfolio accordingly.

Public data release – The MDR and IVDR require that clinical performance data for Class III and implantable devices be reported at least annually through the European Database on Medical Devices (EUDAMED), which is available to manufacturers, NBs, regulators and the public.

Impact: Public disclosure of performance data will make it easier to compare similar products. This could feed value-based purchasing decisions and shorten product lifecycles by intensifying competition.

How to prepare: Assess product performance relative to competitors and consider dropping or improving underperforming products. Where appropriate, focus products on patient populations where they offer the greatest performance advantage. Start early to stay ahead of the competition.

Changing role and scope of Notified Bodies – Under the MDR and IVDR, NBs will transition from their current role as industry partners to the primary enforcers of EU regulations. NBs also will have to be designated by the European Commission as competent to certify specific categories of devices and will not be allowed to certify devices outside those areas.

Impact: NB reviews will become more complex, time consuming and expensive. In addition, a shortage of expert resources may mean NBs may cease to certify some products, and backlogs may develop as enforcement deadlines approach.

How to prepare: Make sure your current NB will be able to certify all your products. If they cannot, find an NB that can. Start early to lock in NB resources. Assess the extra cost and resources required to deal with more complex certification processes and adjust portfolios accordingly.

Conclusion – The MDR and IVDR impose complex and potentially costly new requirements on manufacturers. Making these changes will take time, and bottlenecks in certification are likely to develop. So if you haven’t already started planning for the transition, do so now. Expert help may be required to assess needs and make required changes in product development, clinical testing, manufacturing, quality control and post-market surveillance. ICON experts in regulatory compliance and all aspects of medical and IVD device development can help. Contact us at ICONplc.com/devices for assistance. Further download our MDR/IVDR white paper at ICONplc.com/device/EU-Regulations.

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