The European Medical Device Regulation (MDR) is the hot topic in the medical technology industry and affects manufacturers and notified bodies alike. Dr. Cord Schlötelburg, Head of the Health Division at VDE, spoke with Michael Bothe, Co-Head of the Certification Body for Active Medical Devices at DQS Medizinprodukte GmbH, about the challenges and impending bottlenecks from the perspective of a Notified Body.

As of May 26, 2021, the European Medical Device Regulation (MDR) will apply. As a result, companies in the medical technology industry are facing major challenges. Manufacturers, in particular, will have to make a significantly greater effort to place medical devices on the market in Europe under the new legal framework. But that's not all: for some new or tightened rules, their exact interpretation is unclear. In addition, in some cases the EU Commission has not yet created the complete prerequisites for implementing the MDR. The best example is the European medical device database EUDAMED.
However, not only the manufacturers of medical devices are directly affected by the changes of the MDR. The MDR also means that Notified Bodies must meet significantly higher requirements in order to be able to certify under the new legal framework. Of the approximately 50 Notified Bodies under the European Medical Device Directive (MDD), only 20 organizations have been designated under MDR to date. Industry representatives are therefore warning that there are not enough Notified Bodies available to ensure a smooth transition to MDR.
We got to the bottom of this issue and sought a conversation with a Notified Body. Dr. Cord Schlötelburg, Head of the Health Division at Germany's Association for Electrical, Electronic & Information Technologies (VDE), spoke with Michael Bothe, Co-Head of the Certification Body for Active Medical Devices at DQS Medizinprodukte GmbH, about the challenges of the MDR from the perspective of a Notified Body.

DQS Med was listed in the European NANDO database as a Notified Body according to MDR on 08 August 2020. How did the designation process proceed?

Bothe: Good but with a lot of work. The requirements of the MDR are high and this is also reflected in the designation process. We invested about two and a half years in total, including all the preparations. Operationally, we had the most to do with the ZLG, the Central Office of the Federal States for Health Protection with regard to Medicinal Products and Medical Devices, and less with the EU Commission itself. The cooperation with the ZLG was very good and professional.

And the cooperation with the EU Commission?

Bothe: A large part of the workload resulted from deviations that were identified in the joint audits by the ZLG and the EU, which we then worked through. Here you could tell that the process was still new. There were inconsistencies between the ZLG and EU assessments due to different interpretations of requirements. This led to additional work. In addition, we had to find, onboard and train many experts.

Were the specialists the biggest challenge?

Bothe: Yes. We had to prove that both quality management system auditors and product file auditors were available to us in sufficient numbers and with the right range of expertise. The MDR has significantly increased the requirements for auditing technical documentation and thus product files in particular. This also applies to product file auditors, who must demonstrate at least 2 years of relevant experience or 5 audited product files under the MDD within 2 years. This was difficult to realize in individual cases, especially in technical niches. There are then simply few experts. We have therefore trained more than 600 standards internally within the framework of more than 100 webinars in 3 levels in order to impart the relevant knowledge and provide evidence of this.

So all Notified Bodies are looking for suitable skilled workers?

Bothe: Yes, and add to that the 20 or so organizations that still want to be. It's important to be flexible with onboarding and use digital tools. We would have had a hard time delivering our internal training as classroom workshops. Our product file reviewers mostly work from home and can sit anywhere. We have brought in some of our professionals as freelancers. And we can also handle the ongoing training of our specialists digitally to a large extent. Nevertheless, the cost is high. I therefore have my doubts as to whether the pending designations of other organizations by the EU will take place quickly enough and whether everyone will be able to keep it up.

That means we have to assume a shortage of Notified Bodies?

Bothe: I think you have to differentiate here. Notified bodies have different scopes, i.e. they cover a different range of disciplines. The financing model of a notified body depends on this. It makes a difference whether you only certify quality management systems and inspect product files, or whether you also offer type examinations as a full-range provider. The costs for personnel and technical infrastructure differ. In addition, you need different specialists. Ideally, the available scopes and capacity supply will perfectly match market demand from the beginning of 2023. However, I have considerable doubts that this will occur.

Shouldn't there actually be enough Notified Bodies now, and not just in 2023? May 26, 2021 is the start of validity of the MDR.

Bothe: Actually, it will. But we see that manufacturers are taking advantage of the transition period until May 2024 as much as they can. This means that a large proportion of the directive certificates will be extended again before May 26, 2021, and will then be valid until May 2024. And that's what worries me the most, because we have to assume that this will cause a big bow wave of MDR certifications to start rolling toward us in mid-2023. The existing Notified Bodies will not be able to cope with this, even if a few additional organizations are designated by then.

Why are manufacturers still so cautious about MDR certification?

Bothe: There are many reasons for this, and the economic ones are probably the most important. If a manufacturer can keep an established product on the market longer and not have to change it, they will extend the certificate as long as they can. Another reason is the corona pandemic. It has had different effects on manufacturers. Some have been able to increase their sales and others have not, such as in the dental sector. Then manufacturers are cautious about new certifications. Overall, the smaller manufacturers in particular are having a hard time with the requirements of the MDR. We see time and again that there are still many gaps in knowledge. Added to this are the costs. For a Class III product, for example, every single product file has to be checked, which leads to enormous time requirements and high costs.

What, then, are the most common problems that arise in practice with MDR certification?

Bothe: That's difficult to answer in general terms. The devil is in the details. It also depends a lot on whether it's an experienced or less experienced manufacturer. From the perspective of an experienced manufacturer, not everything is new under MDR. That's why we recommend having a pilot product of a higher risk class certified first to see what, if anything, is stuck. What we generally see more often is that the requirements for the documentation provided by the manufacturer are underestimated and that we then have to request some additional information. But we also see other problems. Smaller companies, for example, sometimes lack English language competence, which is important in the MDR environment because otherwise experts from non-German-speaking countries cannot communicate with the manufacturer.

And what experience have you had with less experienced manufacturers?

Bothe: In initial discussions, we sometimes find that basic things are not in place or that the quality management system in accordance with ISO 13485 must first be adequately set up. Here, the requirements are more comprehensive than before. This also means that we always look at the product files before considering an audit of the quality management system. Initially, we look at the organizational structure of the manufacturer and the product portfolio. Then we can make an estimate of the effort required. What we often experience is that in the case of Class IIa or IIb products, individual product files from the product groups to be certified cannot be provided by the manufacturer.

In your view, are there any other shortcomings that make MDR certification more difficult?

Bothe: Due to Corona, we can only carry out audits on site in exceptional cases. However, we have made the experience that remote audits are a good alternative and work well in most cases. However, we are still not allowed to perform remote audits for initial certifications. This is hindering the transition to MDR. Another problem relates to standards. There are no standards harmonized with MDR yet. And it is not foreseeable at the moment if or when we will have them. The same applies to the Common Specifications announced in the MDR. With one exception, these are not yet available. All of this creates uncertainty on the part of manufacturers and notified bodies. The interpretation of the term "significant changes" also remains difficult. Although there is an explanatory MDCG Guideline, many questions arise in implementation practice.

What do you recommend with a view to implementing the MDR as smoothly as possible?

Bothe: That which is also useful at Corona times, namely flatten-the-curve. As it stands right now, we should expect a large number of MDR certifications before the transition period ends on May 26, 2024. Most likely, especially those manufacturers who need a Notified Body for the first time under MDR will be too late and will not have a chance to find one with free capacity and suitable scope. It would be very helpful to flatten this certificate bug wave. New MDR manufacturers should therefore best start pilot projects this year or early next year and get the MDR certificates for the higher risk classes underway.

Michael Bothe

Michael Bothe is Head of the Notified Body for Active Medical Devices and is also a lead auditor. He is also involved in standardization at the German Institute for Standardization (DIN) and the German Commission for Electrotechnical, Electronic & Information Technologies (DKE) and coordinates continuing education activities for customers. His interests include integrated audits as well as process optimization of conformity assessment procedures.