Medical and Regulatory Affairs

Premier Voices #6: Operationalizing the New MDR With Janet Kube (Part 2)

The European Union’s new Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) are putting a lot of pressure on the medical device industry. These are big changes with far-reaching implications, and if there’s a common denominator among them, it can be summed up in one word: more. In this episode of Premier Voices, Janet Kube continues her look at what medical device sponsors need to know – and what they need to be doing now before the deadline hits.

What do the new regulations actually do?

The MDR expands the definition of a medical device (and its related definitions) to include a wider range of products. Items not previously classified as medical devices, such as cleaning and sterilization products, custom-made devices, and devices used for control or support of conception are newly regulated. The IVDR, for its part, identifies devices according to four redefined classes.

There are more rules that will require you to take more action, spending more time (and money) in the process. Requirements will be more stringent. Comparative evaluations will require far greater effort. And companies that don’t comply risk having their products pulled from the European market.

Recognizing this, the EU Council had the foresight to build in long phase-in periods for the new rules — three years for devices and five years for in vitro diagnostics — and we’re in the thick of the transition now. These are significant revisions, as we observe in the new episode, and we’ve been given time to digest and to plan for good reason.

Some of what you need to prepare for:

CE mark recertification. The transition to the new medical device and in vitro device regulations will require diligence on all existing CE-marked certificates between 2020 and 2025, the effective date varying based on the product. All products will require recertification over a period of about four to six years.

Up-classification. Many devices will shift to a higher level of classification within a hierarchy that ranks devices as Class I, IIa, IIb, or III in ascending order of risk. For example, in vitro fertilization, diagnostic, spinal, active devices, and implantable devices will move up to Class III. Software, long regulated as Class I, will be upgraded to IIb and will require review by Notified Bodies (NBs). Speaking of…

Notified Bodies. These organizations, accredited by EU member states to assess products for market approval, will shoulder a heavier workload and must be recertified and redesignated under the revised rules. The number of these entities has already declined due to stricter accreditation requirements, leaving only about 60 overburdened NBs in existence today. Expect that number to keep falling as these groups decline to seek accreditation under the updated regulations. If you haven’t done so yet, get hold of the NBs you will want to work with in the future to make sure they’ll be available to meet your needs.

Comparative evaluation. It will be much harder to demonstrate a device’s efficacy and safety by pointing to data that shows the device is substantially equivalent to one already on the market. In the future, you’ll need to generate much more data, and it will be more rigorously interpreted. What’s more, a manufacturer performing a comparative evaluation will need to get agreement from the company whose device it is using as the basis of comparison, further complicating the process.

So what do you do now? Listen to our podcast for more insight on this timely subject, and assemble your operational team and start planning and building your strategy. The effective dates of the new rules — May 2020 for the MDR and May 2022 for the IVDR — are still far out enough to allow for the careful and robust planning necessary for successful implementation.

Full presentation:

Additional resources:

European Commission site: