Interview with Inette Nieveen on the effects of the Medical Device Regulation in Europe

In the previous interview with Inette, she shared her experiences with implementing the EU-MDR. In this interview, she will share with us the opportunities and challenges within the EU-MDR. 

Inette, will the MDR affect the Quality Management System?

Yes, it will be a massive overhaul of processes and procedures; it will take time and a lot of effort. Most of the processes within a Quality Management System will need to be reviewed and revised. Currently, manufacturers are updating their QMS to the latest revision of ISO 13485 and we see many manufacturers combining the updates for ISO 13485:2016 certification and the MDR requirements. 

What are the consequences for the Supply Chain?

Previously in the Medical Device Directive (MDD), distributors and importers were not defined and less restrictive requirements were defined for authorized representatives and legal manufacturers. This new topic dealing with obligations and liabilities of all economic operators in the supply chain, brings the medical device field in line with other EU regulations. All relations in the supply chain will be affected and this forces a manufacturer to define the landscape in which he operates with other economic operators. It will end up in reviewing contracts, redefining responsibilities and liabilities in the agreements between parties and the rework of several processes, like complaint handling and Vigilance reporting.

And for the Eudamed database and the introduction of UDI?

Yes, there are major consequences for labeling and data submission in the Eudamed database, as well as for processes that deal with traceability, identification and transparency. (Also read the blogs on EU UDI and FDA UDI). The UDI implementation can start once the EUDAMED database is ready. We expect that the first wave (Class III devices) need to have implemented UDI coding in 2021, followed by Class IIa/b in 2023 and Class I in 2025. Although the UDI requirements in the US differ in some aspects from the MDR requirements, manufacturers who have implemented UDI for the US, will have reduced workloads.

You have already started working on MDR implementation projects, how are manufacturers responding to the new MDR?

Most of them are not happy. They need to invest significantly to update processes, meet stricter clinical requirements, implement UDI and so on. It takes time and money to keep their products on the market. They ask themselves: ‘Does this make our products safer?’ 
Their biggest concern is how to run the implementation projects effectively. What level of compliance needs to be achieved? Although the MDR covers more than 300 pages, there are still a lot of blanks to be filled in by means of Implementing and Delegating Acts and Common Specifications. 
Of course, there are RA/QA managers who know what to do to get into compliance, however, they struggle with getting the overall roadmap clear and moreover, how to convince their management of the additional budget and resources. It helps if we bring this message across to the upper management. By conducting the GAP analysis, presenting the findings and showing the Qserve implementation roadmap, we have repeatedly convinced management of the impact of the MDR on their business. More important, we made them aware of the urgency to get started now. 

Where do you see challenges for Medical Device manufacturers to stay or a become in compliance?  

Time, money and resources. Projects must be well planned; many people have to do this in addition to their existing work. Companies may encounter difficulties due to the lack of resources. In addition, it requires the right skills, people must have good knowledge of quality systems and regulatory issues. Companies require manpower that is capable, knowledgeable and experienced. This is a definite challenge. 
In addition, if there are still significant clinical gaps it will also require significant investment in clinical research. We advise our clients to start in a timely manner, and if applicable, use the transition period to perform post-market clinical follow-up, to be able to avoid more costly pre-market clinical trials in a later stage. 

What is your expectation of what will happen in the market?

Becoming compliant with the new regulation requires resources, time and most likely investments (e.g. in clinical investigations, UDI). The question is if small enterprises can and will invest in their current product portfolio. Now these small companies are often innovative and bring new ideas to the market, however, will they continue if the cost-benefit ratio changes? A possible scenario is that venture capital will help, while on the other hand, chances are high that part of the start-ups will be acquired by other manufacturers.


Where do you see the opportunities? 

As a manufacturer, you may profit from the new regulation as well if you timely secure the certification under the MDR. You will be able to secure your market position as you have now. It is very likely that your competitors will not have the certifications finished on time, and the consequences are that, for the time being, competitors will not have market access to sell. This leads to a competitive advantage for those companies who started and finished compliance with MDR in a timely manner. It is also likely that competitors will reduce their portfolio or parts of it due to the high costs of collecting clinical data in order to keep the current claims and intended use of the marketed devices.


What is the Qserve approach to help manufacturers? 

We see that in every company the situation and compliance level are different. The needs of our customers also differ. Still, in most cases, we have started with a GAP-assessment covering technical documentation and QMS. The results have led to a master impact matrix, which in turn gives the input for a strategic plan which outlines the realization phase and defines the projects that need to start in the implementation phase.

*Qserve has designed an EU-MDR First Aid app that will give you a quick insight in your current compliance situation.   

If you look at Qserve, what makes us unique and efficient? 

One of our board members, Dr. G. Bos was heavily involved in the preparations of this new regulation. He knows exactly the background of the requirements and therefore, our MDR team can effectively implement practical solutions.
We have a practical approach. The combination of Clinical, Regulatory & Quality knowledge and experience in the medical device industry, together with our willingness to go the extra mile for our customers, is what makes us unique and efficient. 

We will regularly interview one of our consultants about the EU-MDR. Next time our Quality expert, René Schings, will share with us the ins and outs of MDSAP. If you have a specific question, send a mail to marketing@qservegroup.com and we will try to get your question answered in one of the upcoming interviews.

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Inette Nieveen
Post date: November 13, 2017
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