Class I Medical Devices under MDR with Erik Vollebregt (PART 2)
In this second part of the discussion with Erik Vollebregt, we will continue to help Medical Device manufacturers regarding the MDR Corrigendum 2. But we will also include more information about pure Class I devices.
The manufacturers with only class I devices will be surprised as there are also more requirements they have to follow per MDR. For example the creation of a QMS, the registration of economic operators, UDI…
So you should really understand those requirements as this can also increase the cost. I used the example of someone contacting me from the US to register an FDA class 1 product in EUROPE. And when I listen to him all the requirements and the cost of it, he was really surprised.
Learn to remain compliant just by listening to this episode.
Who is Erik Vollebregt
Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software and protection of personal data. He is an expert in life sciences regulation at the EU and Dutch level, with a focus on contracts, regulatory litigation against competent authorities and M&A.
Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms.
He actively contributes to law and policy development at the national and EU levels via membership of specialized committees at branch associations and the European Commission. Erik also works as an arbitrator in medical devices related disputes and is regularly retained as an expert witness in foreign litigation. Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish.
Chambers Europe 2017: Erik is known for his specialism in regulatory work, which covers medical technology, devices, and products as well as for biotechnology. Clients confirm his strong capabilities, with one saying “he stands out to me. Whenever I work with lawyers he has been the best, with a solid scientific background. He has the perfect combination of skills and experience.”
Link to the episode
- Episode 53: https://podcast.easymedicaldevice.com/53
- Erik Vollebregt Linkedin: https://www.linkedin.com/in/erikvollebregt/
- Axon Lawyer Website: https://www.axonlawyers.com/
- Slide Presentation: https://www.slideshare.net/ErikVollebregt/mdr-and-class-i-medical-devices-presentation-203092176
- CEN/TR 17223:2018 MDR vs ISO 13485: http://tidd.ly/830baa
- Blog post on Corrigendum 2 (Erik Vollebregt): https://medicaldeviceslegal.com/2019/12/09/corrigendum-2-and-the-potential-consequences-for-class-i-devices/
- Corrigendum 2 link: https://data.consilium.europa.eu/doc/document/ST-13081-2019-INIT/en/pdf
- Class I technical file template: https://school.easymedicaldevice.com/shop
3 Replies to “Class I Medical Devices under MDR with Erik Vollebregt (PART 2)”
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Dear Monir and Erik
Thank you once again for another informative podcast!
We are a Class I Manufacturer and will be up classed to IIa (we have been fortunate enough to get an extension!)
I do have a few questions:
Q1. We have a Class I Technical Dossier that is expiring May 5, 2020. We are updating this as we speak but as we are not MDR yet do we update this file to MDD standard and self certify the MDD?
Q2. We are almost finished another Class I Technical file, which will also be upclassed to IIa but as this will be completed in the 30 days do we continue on as normal with this products being a Class I and self certifying the MDD?
Q3. I am assuming there are two ways to go about becoming certified by a Notified Body. One way is to achieve ISO 13485 certification and then have our TD audited by a NB? As I have had one NB tell me to just worry about the ISO 13485 now and then the MDR at a later date? Second way is to have the ISO 13485 and the TD reviewed and audited together. Which is more advantageous to a manufacturer and is the least expensive and less time consuming?
As Erik had advised we have plans to begin our MDR in 2021, hopefully there will be more NB near us in Australia.
Thank you in advance!
Shannon
Hi Shannon,
Really sorry that I am answering this question so late.
First I wanted to thank you for them as many people may have the same.
Here are my answers:
– Q1: If your product is class I under MDD and also under MDR, then you need to have a compliant dossier before May 26th, 2020. There is no transition period for these dossiers. For these products, they can be MDR compliant now. We are now on a transition period which means that you can apply the MDR requirements to your products so don’t think of MDD anymore for these products
– Q2: For the product that is up-classified with MDR, you can still self-certify them with MDD before May 26th, 2020. But not later. The Declaration of Conformity should be issued before. So then you will benefit from the extended transition period. You can then take some more months to update this to MDR and try to find a Notified Body for your products.
– Q3: With the new MDR, you will need a compliant QMS for Class I products. So I think you need first to think about your QMS so you are on the safe side for your class I devices. But as normally this QMS is certified by a Notified Body, then you will maybe have more advantage if you do both the QMS and Technical Documentation. For sure the price will be less expensive as there are fewer days of audit and travel. For me, this is more a company strategy to define what is best for you. It depends also if you have already a Notified Body or if you need to contact one.
For your last comment. The Notified Bodies are mainly in Europe unless if they open offices outside of Europe to support their customers. In the case you need more information, please send an email to info@easymedicaldevice.com. The answer will be quicker.
Thanks.
Monir
Thank you once again for another informative podcast!