What you need to know about Europe’s new medical device rules


European Union medtech regulationsNew regulations are coming to the European Union, and it’s up to developers to implement changes that will help them thrive in the new environment.

Vicki Anastasi, Icon

The new European Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR) represent one of the most wide-ranging and disruptive changes to recently affect the world’s second-largest medical technology market.

With just a three- to five-year transition period before full compliance is required in 2020 for MDR and 2022 for IVDR, the scope and complexity of this legislation will require significant changes in areas such as product development, data reporting, quality assurance and manufacturing processes. Manufacturers will need to identify which of their products will be affected by the new classifications to ensure they remain compliant.

Additionally, the role of Notified Bodies (NBs) will be restricted by the European Commission to certifying only specific classes and types of medical devices and in vitro diagnostic devices (IVDs) for which each NB can demonstrate expertise. This will reduce the number of NBs available to certify many devices for some time and, in combination with the larger volume of clinical data that NBs will be reviewing for each device, we expect long delays in certification reviews as deadlines approach. Finally, IVD manufacturers will be particularly impacted, as NB review will be required for approximately 90% of products, up from about 10% today.

What steps should manufacturers take to prepare for the new EU regulations?

Early planning is key. As challenging as product testing and reporting requirements may be, the new regulations could present an opportunity to get ahead of the competition.

Complying with the new MDR and IVDR will require significant lead time, especially when preparing clinical studies to certify new devices – and to recertify existing ones. Moreover, you’ll need extra time for expanded NB reviews, and any backlog that may develop.

For IVD organizations that have not previously done clinical trials, developing this capability requires a lot of time and resources. In addition, review of certification applications by NBs will take time since NBs must develop the capacity to review IVDs.

So, for MDR and IVDR, early transition will give your products an advantage in the market by providing buyers with credible performance information. Also, it gives early movers an edge in squeezing out other manufacturers competing for the same limited NB resources.

Will it be worthwhile to conduct clinical testing on existing products?

Yes, it’s worth the investment. Developing strategies that demonstrate effectiveness will help you gain and press your market advantage.

The best way to know whether your products are worth the investment is to conduct a “gap analysis” of your pipeline and existing product portfolio. For each product, first determine the category under which it will be certified – MDR or IVDR – and what additional evidence, clinical testing, production process, technical file documentation or other changes will be required to conform.

Next, estimate the cost of these changes, assess how they’re likely to affect profitability and reconfigure your portfolio accordingly. Your analysis may indicate it’s time to drop marginal products with a lot of competition and focus on preparing packages for new, more profitable medical devices where there are fewer marketplace competitors or IVDs with strong evidence showing they support clinically beneficial treatment decisions.

Clinical tests for IVDs differ from those of pharmaceuticals or medical devices primarily in their endpoints. Although drugs and medical devices generally can be evaluated based on how they directly affect a disease or condition, IVDs must be evaluated based on how the information they provide affects treatment decisions.

Consider that the new regulations require uniform performance data reporting to a central database, which will make it easier for health system buyers to compare product performance head-to-head. As a result, any product that shows a clear performance edge could gain a decisive market advantage.

CROs can help assess portfolios for product viability under the new regulations and in creating the real-world evidence needed to conform to the new regulations.

Vicki Anastasi is VP & global head, medical device & diagnostics research, for Icon. She has more than 25 years of experience in the medical device industry, with more than 15 years specifically focused on global medical device strategic consulting.

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