I recently attended a webinar hosted by MedTech Intelligence called “EU MDR Lessons Learned.” The webinar content was presented by three industry professionals who are very well versed on the topic: Robert Dostert from DNV Product Assurance; Dr. Bassil Akra from AKRA Team Strategical Solutions; and Michelle Lott from leanRAQA. The team of presenters offered some keen insights into the current medical device regulatory landscape in Europe now that we are roughly 6 months past the EU MDR adoption date.
To refresh your memory, it was announced by the European Commission in 2017 that the old Medical Devices Directive (MDD) and Active Implantable Medical Devices Directive (AIMDD) would be replaced by a new, more robust set of medical device regulations called the Medical Device Regulation (MDR). The goal of the European Union (EU) MDR was to update and strengthen the EU’s legislation for medical devices so that it could better ensure a high level of health and safety protection for EU citizens.Like many well-laid plans, the MDR was impacted by the emergence of COVID-19; it was supposed to go into effect in May 2020, but medical device manufacturers were provided with a reprieve when it was announced that this date would be extended to May 2021. Manufacturers who already achieved CE Mark under the old MDD can continue to keep their devices on the EU market until the year 2025, but no new CE Mark certifications will be issued as of May 2021.
So, manufacturers wishing to release new medical devices to the EU market, and those wishing to continue to sell product past the year 2025, must comply with the new set of regulations. By all accounts, this is easier said than done for a host of reasons which I will summarize below:
Dynamic expectations. Because the regulations are so new, all stakeholders (the European Commission (EC), National Competent Authorities (NCAs), Notified Bodies (NBs), and original equipment manufacturers (OEMs)) are learning together. As the NCAs become more educated about the intent of the MDR they are holding the NBs to more rigorous reviews, which in turn means that the NBs are evolving their processes to ensure OEMs have a higher likelihood of success. Clarification on vague expectations is being sought from the EC, and when clarity is provided, the process continues to evolve. OEMs who thought they understood the expectations a year or two ago may not be in a position to comply based on today’s expectations. This quickly changing landscape makes the hurdle of compliance considerably challenging.
Limited product-specific guidance. Compounding the issue of dynamic expectations is the lack of product-specific guidance that has been provided by the recently formed Medical Device Coordination Group (MDCG). In many cases, OEMs (and NBs) are navigating the submission process without explicit guidelines related to their particular device type. As you can imagine, expectations for an in-home dialysis machine may be vastly different than a breast pump, but until official guidance is provided on various device categories, stakeholders will be making their best guesses.
Limited resources. It was well predicted when the MDR was announced that the future would hold a sticky situation for NBs and OEMs requiring NB services. In 2017 when the EU MDR was declared, there were 53 qualified NBs in Europe who were servicing the current MDD applications, and they were considered shorthanded at the time. As of today, that number has dwindled by more than half; there are now only 25 qualified NBs who are qualified to service applications under the new EU MDR. The designation process for NBs to switch over from MDD to MDR is lengthy; it has been reported to take up to 18 months in some cases. Beyond the time commitment, there is the burden of complex and varying requirements for different medical device product categories. So for example, an NB that was qualified to review submissions related to invasive and non-invasive devices back in 2017 might not have designation to review both categories today.
Lengthy timelines. Due to the shortage of qualified NBs and a smaller selection of those who are qualified to review specific categories of medical devices, OEMs are being subjected to long wait times just to get an application spot; it has been reported that some NBs are placing OEMs on waitlists for up to 8 months before they can even engage. OEMs have three attempts to get through the process of EU MDR certification, and even if they were to comply perfectly with all requirements on the first round (which is pretty much unheard of) it can still take a minimum of 7 months, and more likely about one year, to get through the process. But then, even after successfully receiving verbal approval, it can take another 6 months for OEMs to actually receive their certificate. If you do the math, that’s just over 2 years to get through the whole process!
Challenging regulations. The new EU MDR requires proof of a rigorous product development process, especially as related to Quality Management System requirements and technical documentation. One of the webinar presenters indicated that the new mandate doesn’t just necessitate simple updates to OEMs’ systems; it essentially results in the need to start over from scratch. Specific areas cited as most challenging for OEMs to comply with include: clinical development plans, risk management plans, usability verification and validation activities, labeling requirements, and post-market surveillance requirements.
To complicate things further, there is the issue of obtaining clearance to sell medical devices in the U.K. and Switzerland, two significant markets that do not fall under the EU MDR. It is well known that the U.K. market has been affected by the results of Brexit. However, it may be lesser known that Switzerland has its own set of medical device regulations (MedDo) that set it apart from the EU. Medical device manufacturers have some leeway in staying on the U.K. market until 2023 if they have already obtained CE Mark and write a declaration of uniformity. However, this is only delaying the need to obtain yet another country-specific certification in addition to complying with the new EU MDR.
Despite what I have described as a stressful transition period between MDD and MDR, it is not all doom and gloom. There are OEMs who have successfully made it through the process of transitioning their MDD CE Mark to MDR CE Mark – in fact, there are about 25 of them to date. Their success was fueled by doing their research, proactively seeking the advice of NBs and industry experts, requesting clarification on expectations, and not waiting too long before taking action.