Medical Device Regulation: "We see many problems with the current timeline"

Improved patient safety. That’s the ultimate goal of the new EU Medical Device Regulation (MDR), which was published in 2017. Starting May 2020, it will apply to all medical devices in the EU. However, a growing number of people predict that this will be difficult to implement.

Hans-Peter Bursig of the German Electrical and Electronic Manufacturers´ Association (ZVEI) describes the problems, illustrates the completed steps and reveals the role that Brexit plays in this setting.

Mr. Bursig, the MDR was published in 2017 and aims to improve patient safety. That’s actually a good thing. Why does it face such harsh criticism from medical device companies and their suppliers?

Hans-Peter Bursig: The new regulation does not improve the safety level from the perspective of medical device companies. Medical devices are already very reliable, effective and safe. Now there are readjustments at several points, including added regulatory controls and inspection measures, as well as very precise specifications and instructions on how to perform certain processes. It increases safety as a result of more effort on the part of the manufacturers and the Notified Bodies. Added safety is always a good thing. However, the criticism refers to the fact that all of these measures will have to be taken for all devices during a very brief transition period. This also includes legacy devices that did not require a safety corrective action in the past ten years. This calls for an extensive effort of companies, which can only be managed with considerable time and expenditure during the remaining time. As a result, many manufacturers seriously consider a product portfolio reduction.

This would especially affect niche products that cater to children for example. Do you think this might really happen?

Bursig: We believe that this will very likely be the case. We surveyed our members, which include large enterprises, as well as small and medium-sized medical device companies. On average, between five and ten percent of the devices these companies currently have in their portfolio will likely disappear from the marketplace. This will initially affect many product variants, such as an ECG device that comes in seven different variations. A company then might only offer five variations of this device in the future. Many variants will no longer be available on the market because manufacturers will carefully review whether the considerable effort for the new conformity assessment and ongoing documentation update requirements pays off for them. And this might also affect devices that were specifically designed for children.

Is it possible that devices might not be taken out of the product portfolio but instead get relocated to the FDA sector?

Bursig: We don’t think this will happen. Needless to say, manufacturers can always choose to no longer market a product in Europe and take it to markets outside the EU. However, manufacturers always need to consider whether this is a step that pays off in the end. After all, the company subsequently manufactures a device for the U.S. market, which is not approved for the European market. That’s why I don’t expect this to happen on a large scale.

You already mentioned the "Notified Bodies". The re-designation process is very slow. At the same time, several appointed bodies in the UK will be eliminated due to Brexit. Do you think the authorities can still keep to the schedule and re-designate the Notified Bodies in time?

Bursig: To put it in a nutshell: no. There are currently 58 Notified Bodies in Europe under the existing Medical Devices Directive. They are already operating at full capacity. Companies already reveal that the review and certification processing times for new products have increased considerably because the Notified Bodies have reached the maximum level of output. We also know that startups, in particular, have had great difficulties in actually finding a Notified Body that still accepts new clients.

Thanks to the new MDR, the Notified Bodies must now get re-accredited. This is far from being a mundane issue. The audit and designation of a Notified Body is a long and complicated process. There are joint assessment teams – also consisting of other member states of the EU - who ensure that the Bodies meet all requirements and are fully functioning. In the best-case scenario, this designation process takes twelve months. Right now, there is one single Notified Body designated under the MDR so far - and it's located in the UK. It will get de-designated post-Brexit. There are currently about twelve additional Bodies in the designation process. They are expected to be the first Bodies that can conduct certifications under the MDR during the second half of 2019. That’s much too late from a manufacturer’s perspective. Since the transition period ends on May 26, 2020, they want to certify their devices by December 2019 at the latest. After all, manufacturers must allow for corrections to individual components the Notified Body finds fault with. Manufacturers might take up to six months to make these modifications. Subsequently, all processes that have not been completed by December barely stand a chance to be finalized by May 26, 2020. Right now, we don’t expect there will actually be an adequate number of Notified Bodies by the end of 2019 that can certify all manufacturers or their devices in Europe by the end of the transition period.

Do you know how the EU responds to these circumstances? So far, it has maintained that everything is right on schedule.

Bursig: That's still the position. It goes without saying that Brexit adds to the issue. Many manufacturers are hoping for a temporary emergency solution that will allow them to bring products that are certified under existing directives with the former valid CE marking to market during the transition period. However, if this CE marking was obtained from one of the four UK-based Notified Bodies, it will no longer be valid post-Brexit. That’s why we don’t understand why the EU Commission keeps claiming "we are on track". We see many problems with the current timeline. We believe a smooth transition is very unlikely.

What changes or revisions would have to be made so that everyone benefits from the new regulation?

Bursig: One and a half year ago, we – along with all other healthcare technology associations – have already warned that the three-year transition period is too short, especially if all Notified Bodies must obtain a new designation. According to what we know from our member companies, the manufacturers are as prepared as they can be and did their homework. Manufacturers are now waiting for the newly designated Notified Bodies to start the CE marking process for their devices. But as I have mentioned earlier, even if they would be in place by fall 2019, it would still be difficult to finalize all processes by May 2020. That means, the EU would have to communicate what the Notified Bodies should effectively audit and review in the remaining time. Just picture an audit team visiting a medium-sized company with several hundred products in its portfolio. The team must review the technical documentation of every single product - because it requires a full recertification process. That’s simply impossible to do in the allotted time. That's why the only thing you can do is to modify the regulatory instructions and guidance of the Notified Bodies and free up more time. One option would be to initially only request to audit a medical device manufacturer for conformity with quality management system requirements and conduct spot check audits of the complete documentation for individual products. During this first step, a full document and record review is not required. This would be a pragmatic approach because the alternative – to extend the transition period – is in our view not feasible from a political and time perspective. This year marks the next elections to the European Parliament and the new European Commission mandate. This means that policy-makers would not be ready until the end of this year to decide on an extended transition timeline. By then, it will be too late for manufacturers because they would have had to make all decisions at that point. At that point in time, they have adapted the technical documentation and chosen the devices they will no longer manufacture. That’s why we expect the EU to allow some flexibility in the applicable regulatory process and its contents, but for the transition period to remain the same.