Written by Joe Hage in the MedicalDevicesGroup on LinkedIn
You know that nice, little Medical Device Directive (the MDD) you’ve been using for 20 years to get a CE mark? You know it’s going away, right? Zero MDD certificates will be issued after May 25, 2020. And since CE marks need renewing every five years, by May 2025, everyone doing business in the European Union will have transitioned to the new way of getting their CE mark.
The new sheriff in town.
The Medical Device Regulation (MDR) is the new sheriff in town. He may be new, but he’s bigger and badder than his predecessor. You’re going to have to jump through some serious hoops to get your coveted CE mark. Or should I say, your notified body is going to have serious hoops to help you get your CE mark. Is your notified body (NB) up to the task? Are you in bed with the right partner?
Mark Schmark – How hard can it be?
I ignorantly thought, “Any NB worth its salt should be able to give a CE mark. Under this Directive, under that Regulation, whatever.”
A CE mark is the basic requirement for marketing and selling medical devices in Europe. I mean, if a notified body can’t even give a CE mark for someone, how could they even be in business? Then I read Michelle Lott, RAC’s article.
Get your notified body on the phone. Like, now.
Michelle helped me understand these issues. Internalize them. 1. Are they designated? You don’t get to “just do MDRs.” Every notified body has to apply to become an MDR designee. Okay, that sounds pretty basic, right? If you’re in the NB business and you need one, you go get one, right? With a hat-tip to NSAI’s Colm O’Rourke for this data, 68 notified bodies have Withdrawn/Expired/Suspended Notifications to issue MDD certificates (so MDRs are terribly unlikely). Only 55 notified bodies even remain (see list) and, anecdotally, I hear fewer than half have even applied yet. 2. Have they been audited yet? Your NB has to weather a “Joint Assessment audit.” If they haven’t even scheduled one yet, get nervous. And if they had it – and it didn’t go well – get very nervous. 3. What did they apply for? Designations aren’t one-size-fits-all. Did your NB ask to cover your category of products? 4. Did they add staff? Michelle suggests – and a former TUV employee agrees – if your NB hasn’t added 20-30 percent to its payroll in the past three years, they won’t have the talent necessary to cover all the extra work. 5. How do they define “significant change?” This one’s a bit more nuanced. Basically, and whenever possible, you want your proposed product change to be considered “insignificant” by your NB. Because otherwise, you’ll need to apply for a new CE mark right away – and under the more burdensome MDR. Since each NB has its own interpretation of “significance,” you may find another NB has a looser definition, one that lets you squeak by without the added disruption.
In sum, you may have the wrong notified body if…
- They haven’t applied for an MDR designation.
- They haven’t scheduled a Join Assessment audit. Or they had one, and it went badly.
- They didn’t apply to cover all your products, current and future.
- They haven’t done some serious hiring in the past few years.
- Their definition of “significance” is too strict.
I think Michelle’s article was super helpful in understanding this thorny issue. If you visit her site, you can download a copy of her Regulatory Pathways Assessment. It can help you work through project feasibility and requirements.
Coda: Can you afford to switch notified bodies?
I talked with Michelle afterward and pressed her. “Aren’t medical device manufacturers even lucky to have a notified body in the first place? I understand NBs are so busy and so under-staffed, they’re not even calling back new-business prospects in a timely way.” She quipped, “And if they can’t get you a CE mark, what’s the point of having them at all?” Touché. And drove home her point, “That’s why I’m telling all my clients to ask these questions. Because if your notified body is out of business, YOU’RE out of business.“
