Transitioning from Medical Device Directive (MDD) CE marking to Medical Device Regulation (MDR)
Ongoing legislative reform within the European medical device market is impacting manufacturers globally, with some supply chain delays inevitable.
In this special Q&A with our Head of Operations, Chris Bint, he explains the changeover from MDD to MDR CE and what Vygon is doing to minimise disruption to our customers.
What new legislative changes are coming into effect?
Medical device manufacturers are being called upon to transition to new legislation that aims to reinforce the safety and efficacy of products on the market.
This means products approved under EU MDD (European Union Medical Device Directive) CE certification need to be recertified to EU MDR (European Union Medical Device Regulation) CE standards by 21 May 2024.
What challenges are you facing?
The amount of work and time it takes to register a product for MDR averages around five times longer than that of MDD.
Plus, the number of notified bodies available to assess and certify for MDD is significantly lower for MDR – approximately 60 for MDD versus 34 designated bodies for MDR.
As a result, there is limited capacity for products to be registered and recertified to MDR.
Will Vygon products be affected by the transition to Medical Device Regulation (MDR)?
Products with MDD CE marks have expiration dates on them and we know from our stock management that some will expire within the next six months. Due to the extensive nature of the recertification and limited capacity for notified bodies to approve MDR certification, we anticipate supply chains will be impacted.
As the Medical Device Regulations paperwork is resource-intensive and takes considerable time to reach and pass the approval stage, some of our partner suppliers are assessing whether it is still commercially viable for them to sell products within Europe. As a result, we have been considering new relationships with alternative suppliers to broaden our supply network.
Vygon’s own products, specifically those manufactured in Germany, will be affected too. However, because we act as Germany’s UK RP (Responsible Person) and have confirmed derogation status from the MHRA (Medicines and Healthcare products Regulatory Agency), and a derogation in the EU from Bezirksregierung, Köln, we can continue to manufacture and sell agreed products for the UK market after the original CE certificate, issued under MDD, has expired. Further information about this will be shared with our customers of these products in the coming months.
Whilst this transition will require some amends to our internal processing and coding of products, we are working tirelessly to minimise disruption.
What is Vygon doing to protect our customers?
We are very concerned about how the MDR changeover will affect our customers and the supply of essential life-saving products to hospitals.
These legislative changes have been a focus for the past two years and we have tackled the situation head-on, by:
- Building up stock of our CE marked products before the expiry of the MDD certification – to help ease stock flow concerns.
- Preparing MDR files for all of our product lines and collaborating with notified bodies.
- Communicating with governments and authorities, alongside other members of the European medical device industry, on the reality of the MDR situation.
- Proposing the manufacture of non-CE marked products, which remain identical in safety and efficacy of all of our products, but don’t have the physical marking on the packaging.
Despite our best efforts, many of the factors around certification are out of our hands, so our customers will be contacted if we expect any delays around their orders.
Is Vygon the only manufacturer impacted by this?
No, this is a global issue. A recent survey conducted by MedTech Europe, a European trade association for the medical technology industry, found that more than 50 percent of respondents—representing about 70 percent of the medical device market—planned to reduce the number of products sold in the EU because of the MDR transition.
Is there anything Vygon customers need to do?
No. We will be in touch with individual customers in due course if we have any concerns relating to the products that they purchase from us.
We also want to reassure our customers that we're doing everything that we possibly can to avoid disruption and gaps in supply. Anyone with specific questions about the changes can also contact us directly by email at: email@example.com
Head of Operations at Vygon (UK) Ltd