Although the new Medical Device Regulation (MDR) is now officially effective (in co-existence with the Medical Device Directive, MDD) we’ve noticed that some companies are well on their way with the transition (mostly EU companies) but there seems to be only a small percentage of US companies that has actually started to transition from MDD to the MDR. Especially for Regulatory Affairs (RA) managers this might be frustrating because they are well aware that from short-term perspective sticking your head in the sand, in the long run, might cost you serious money. Here’s why.
MDD TO MDR
For those who haven’t yet had the time to investigate what (mandatory) changes the future holds in the Medical Device field, we can summarize it as follows: requirements regarding your product are increasing and becoming stricter. Examples are requirements regarding, risk classification, clinical evidence, Economic Operators, and Post-Marketing Surveillance. All currently certified Medical Devices (MDs) must be re-certified in accordance with these new requirements.
First of all, companies are well-advised to perform a GAP-analysis to see how they want to proceed with their product. Three likely outcomes could be:
- You find no go GAPs which means ‘no worries’.
- Major GAPs meaning there’s a lot of work and you should start rather sooner than later.
- So many GAPs that you might consider discontinuing your product and withdraw it.
This implies that companies with products on the market within the European Union who find themselves in the second category will need to come up with a transition plan to be compliant with these new rules and they have until May 25th, 2020 to do so. A short calculation tells us that the countdown is at two and a half years at this point.
To assist RA managers eager to start a possible transition we’ve lined up some situations that might motivate all their colleagues to set things in motion. We suggest exploring the three most likely options that could be considered.
1. WHAT IF I DON’T?
Definitely a bad idea. The new MDR does not allow for grandfathering meaning that products that are currently on the market will not automatically be approved to stay on the market. So, if you choose not to transition to the MDR your product will no longer be allowed on the European market and consequently, you will lose income in other countries where turnover is dependent on a valid CE-mark.
2. I’LL DO IT LATER
Tempting, but not a good idea either. To explain this, let’s have a look at the math. To be compliant with the new MDR there are activities that have certain throughput times.
For example, let us assume that your clinical evaluation gap analysis shows that you need to upgrade your clinical data with data from a Post-Marketing Clinical Follow-up study (PMCF). If we pivot these numbers against the time left until you lose your CE-mark, we come to the following:
Activities that would have to be performed against the time it would take and the time that is left in months.
All these activities alone leave you with ‘0‘ months left until your CE mark (read: market approval) expires if you aren’t compliant with the new requirements. So actually, we can say that every moment that companies are delaying the transition to the MDR they will be facing a loss of revenue from the marketed product.
3. START NOW
Yes, we agree. This does not mean that you will be overwhelmed by additional work that can’t be handled.
For instance, your strategy on extending clinical data can be considered via Post Marketing Surveillance while still under the MDD using a PMCF study to gather this data. Under the new MDR, this collection of clinical data without a CE-mark will be considered a clinical investigation, which is subject to far stricter requirements. In that case, you’ll have to set up, for instance, a new randomized controlled clinical study with a 100 patients, a 6-month patient follow-up, and at 10 different sites which is a very costly process with patient insurance, submittal to the Competent Authorities and longer timelines than a PMCF. And also for other issues, a pragmatic approach can often be chosen so that your product’s certification remains valid and continuity of sales is not hampered by regulatory issues.
ARGUMENTS & BUY-IN
We can assure you that securing buy-in from the decision makers and different stakeholders in your company is essential in situations like these. So to pave the way we’ve lined up some arguments to use in persuading that you need to start today.
Since it all usually comes down to commercial considerations, this is likely to be your strongest argument. Here are some examples to paraphrase the money issue:
- Loss of revenue in all countries where turnover depends on a valid CE-mark
- Correct expected projections beyond 2020
- Losing business will eventually result in a loss of qualified staff
- Increased investments will be required to make up to regain lost market share
- Investors are very aware of the MDR and usually require a transition plan
- The company’s reputation is at stake
The implementation of the MDR or the transition, if you will, is most likely an extensive project. And this actual transition is something we’ll get back to in another blog. To put it shortly, all companies are strongly advised to come up with a comprehensive transition plan including:
- Relevant differences
- Risk Class Determination
- Conformity Assessment Procedure
- Top Management Awareness and Commitment
- Implementation Plan
- Assessment Partner
- Product Documentation
- Quality Management System
- Post Market Activities and Reporting
In conclusion, although the deadline of May 2020 seems far away, it really is false security. To ensure continuous compliance of medical device products to the new legislation, i.e. the MDR, a swift start and a solid plan are necessary. This will bring peace of mind to any Medical Device company because business continuity is assured.
So instead of waiting around to see what the future holds, get started and find out where you’re at. And if you’d like some more specific information don’t hesitate to leave us a message.
Blog by: Nick Veringmeier - Xendo