The Impact of the Medical Device Regulation (MDR) on EU Notified Bodies

With the recent announcement that the Medical Device Regulation (MDR) will be extended to May 2021 due to Covid-19, I sat down (Virtually of course) with a talented Lead Auditor who is currently working for one of the world’s largest Medical Device Notified Bodies to discuss some of the impacts of the MDR on industry and EU Notified Bodies.

1.     Could you explain exactly what the MDR is and why is it being brought in?

The MDR is a combination of the previous Medical Device Directive (MDD) and Active Implantable Medical Device Directive (AIMD). These new regulations have far higher requirements regarding the Quality of the product. In the past manufacturers had a number of device failures so the EU commission, to avoid future lack of safety in devices are trying to control the manufacturers way more. Due to the new regulation, device classifications often change, so class 1 devices may now be class 2A or even 2B and have a new set of requirements they must keep to. Every manufacturer needs a Notified Body especially for higher risk devices as they need certificates so lengthier exchange, higher documentation requirements, longer audit duration and a LOT more money transferred.

2.     What has been the biggest adaptation that manufacturers have had to make to pave a way for the new MDR?

Communication is key. As mentioned before, manufacturers must know what kind of class their device is and there may be a difference in class between MDD and MDR, consider if there is a higher risk. This will give them the requirements they need to change to become compliant. They need to make sure that the notified body they currently use is designated to the MDR, if not then you’d better search for a Notified Body that is MDR compliant or will be very soon. The manufacturer then needs to find out which classification their device is which will determine the amount of technical documentation required. They then need to prepare for the audit. Audits in general for MDR, audits for ISO13485 and visits to test/assess the product itself. They need time and resources, most manufacturers underestimate the workload here, companies often see Quality as a department that only costs the company and doesn’t give anything back which is a complete misunderstanding. You need experienced and highly talented Quality members to provide documentation because a lot of the time MDR requirements are misunderstood or ignored and in the end you will lose your certificate. With the MDD, your product can be on the market for many, many years but that doesn’t mean that you are MDR compliant, its completely different, this is a concern for the industry. Extending the MDR to May 2021 is lucky for a lot of manufacturers.

3.     What do manufacturers need to do now they have that 1-year lapse period to ensure they are ready for the MDR?

They need to decide if they’re willing to spend money to create all the documentation as this is not just paper, it requires certain tests, going to the test lab to check to see if the product follows requirements of different standards, EM 60601-1 for electronic devices and also for EMC for example. Clinical trials can take years to finish and you have to get knowledge from surgeons, doctors, they help you, you need to exchange with the Clinical Expert from the Notified Body, if you’re not on the same page with them then you can lose everything, communication is key again.

4.     What do you say to companies who do not invest in to Quality?

With the new MDR because of high requirements it makes it lot easier to plainly say yes or no to giving them a certificate, if you don’t have a certificate you cant put the device on to market, if you’re not on the market you don’t earn revenue and then you’re out, CEO’s need to understand this.

5.     What do small to medium sized enterprises (SME’s) need to be doing to ensure they do not fall below the MDR curve?

Firstly they need complete agreement from management regardless of the size of the company about strategy as there is a huge gap in changes to ensure their device is ready for the MDR. Second is understanding of not underestimating workload as it is immense, it’s tremendously high. For Notified Bodies, work has increased by 30% so need 30% more paperwork, 30% more people, 30% more resources depending on where they were at before. You need time to do the testing and test labs are completely booked so you need to allow time and preparation. Third point is you of course need a designated Notified Body which can be difficult because not all Notified Bodies are taking on new clients due to the bottleneck.

6.     What are the biggest and most frequent challenges that you face when visiting manufacturers?

One thing we have identified a lot is top management not really knowing what quality is doing even in big companies. You must ask yourself constantly, what do you have to do to improve in Quality, this is often underestimated. As a joke we sometimes ask the Quality responsible person if we should write a finding that top management is not understanding anything you do, of course we don’t write this down ??

7.     Notified Bodies have had to suspend on-site inspections recently for obvious reasons, what alternatives have been put in place to ensure momentum for MDR readiness continues?

I can’t speak on behalf of all Notified Bodies but we have implemented remote audits which of course is not completely ideal but we do as much as we can and if everything is not covered then we will cover this during an on-site visit when possible. A difficulty we are facing is that some companies still work with paper and not electronic which makes things more difficult.

8.     In your opinion, has the MDR been unveiled and implemented in the right way? How could this have been improved that should be considered in the future (IVDR implementation for example)?

Many companies were not aware of the impact of the MDR. It was published everywhere so they had the responsibility to check this so the blame should not all be on the European Commission but even the European Commission could not implement everything on time, especially the expert panel and Eudamed. They cannot force manufacturers to improve themselves on the new requirements they implement when the EU commission cannot fully do it for themselves. To improve in the future, marketing campaigns should be created, like you are selling a new BMW, create established forums about the impact of MDR and what they’re going to need to combat this. Next thing is the EU commission have their own interpretation of the MDR, competent authorities of each country have their own interpretation of MDR and Notified Bodies have their own interpretation of MDR, even manufacturers too. To summarise, more transparency, more advertisement, easier understanding of MDR for competent authorities of each country, Notified Body and manufacturer. Since the announcement of the MDR there has been a large reduction in Notified Bodies with only 13 successfully designated MDR Notified Bodies out of something around 60 who have applied as of May 2020, so there is something seriously wrong here. The industry needs Notified Bodies to achieve certifications, it’s great to increase the requirements to make the product safer for the user but you have to give Notified Bodies a chance to catch up, the timelines on this were set very poorly.

9.     Final question, if someone was thinking about a career move into the Notified Body industry, what would you say to them?

It’s very cool, it’s a seriously cool job. Quality is an attitude, not just a department and Notified Bodies live that attitude. You get the chance to see what is going on in the Medical Device market which is super interesting, every single day is different regarding the products and the people you’re dealing with, it’s a very interesting job.

If you come from a Quality Assurance, Quality Control, R&D or Manufacturing background in the Medical Device/IVD space and thinking about a career within Notified Bodies then get in contact at [email protected].