EU Market Entry for Medical Devices: Regulatory Realities

Your investors are excited about the revenue potential in Europe, not to mention what an EU CE mark can do for your rest-of-world efforts. Your business team is engaging with customers and distributors. Your product and engineering teams have built out an EU version of your device. 

And then there’s your regulatory and quality team. They've been trying to schedule a review for your device so that you can get permission to sell it in the EU, and they've been 100% unsuccessful. You’re at your wit’s end. What is going on?

To release your device into the EU, you need what’s known as a CE mark, which serves as proof that you're in compliance with the Medical Device Regulations. A CE mark can only be assigned by a Notified Body, a 3rd party private company certified by the EU to audit manufacturers and certify devices on their behalf. 

Unfortunately, there is a massive shortage of Notified Bodies who are approved under the relatively new EU Medical Device Regulation, and thus a lengthy backlog of reviews to get through. Manufacturers everywhere are struggling to get on the schedule. 

Here is a primer on the EU regulatory landscape with answers to common questions and insights on what to do next. 

Why can't we get an audit scheduled with a Notified Body?

Because they’re all swamped with the same request from other manufacturers right now, and there aren’t enough of them to cover everyone in a timely manner. As of the writing of this article, there were about 40 notified bodies handling medical devices for all of the EU, and not all of them are qualified to handle every type of device. The situation is even worse if you have an in vitro diagnostic device, as there are only 12 notified bodies handling these.

Additionally, most Notified Bodies are prioritizing existing customers, and some Notified Bodies aren’t accepting new customers at all.

Then how did [competitor X] manage to get a CE mark for their device so quickly? 

Either they got on the list for one of the notified bodies very early in the process, or, more likely, they self-certified under the old Medical Device Directive (MDD) before the new Medical Device Regulation (MDR) went into effect in the middle of 2021. They will still need to get an MDR CE mark, but they can market their device in the interim due to the grace period afforded to CE mark holders under MDD. 

Is there some sort of fast track to get a CE mark if we pay more?

No. Some Notified Bodies used to do this, but most appear to have stopped this practice. There could be a number of reasons. Perhaps it causes problems when pretty much every manufacturer is willing to pay for a faster audit and review, and clients have to be turned away. Or perhaps it was just easier to raise all prices across the board (yes, this has also happened). It may also be difficult to promise faster turnaround times when most Notified Bodies are dealing with a lot of new personnel that they’ve had to hire to meet the surge in demand.

Can I apply to multiple Notified Bodies?

You can apply to as many as you want to get on their waiting lists, but you can only do the CE marking process with one of them at a time. In other words, you can’t shop around for a CE mark by giving it to multiple notified bodies at once, hoping one of them will grant it faster.

A consultant told me that they could get us a CE mark quickly. Why can they do it, and our internal team can’t?

A consulting group, like us here at NaviSure, can help you prepare your technical files and your quality management system for Notified Body review. We can also communicate with the Notified Body on your behalf, and advocate for your device. However, neither we nor any other consultant are able to just get you moved to the front of the line. Be wary of anyone claiming to be able to “call in a favor,” or claiming to be “partnered” with a Notified Body.

At one point our team said that they expected we would be on the schedule by the end of last year. That didn’t happen, and we’re still waiting. Why can’t we get a more accurate idea of the timeline?

Your team probably gave you the tentative timeline that they received from their Notified Body representative, who in turn heard it from the EU Notified Body home office. But forecasting can be difficult for the Notified Bodies.

Notified Bodies are constantly managing their resources, which may not be interchangeable (i.e., reviewers for IVDs likely won’t be shifted over to assist with reviews on implantable devices, as these require different knowledge sets). In addition, some devices take less time to review than others. So it’s not as simple as just moving to the next manufacturer on the waiting list. It involves estimating which resources will be available when, which in turn involves estimating how long a certain batch of technical file reviews will take. 

So what can we do?

Prepare. 

FIRST, make sure that all of your documentation is up-to-date and complete. The last thing you want is to be scrambling to put together documents at the last minute when the Notified Body comes calling. Remember, depending on what kind of expertise you have on staff, some components of the technical file may need to be professionally prepared by a third party. In particular, a Clinical Evaluation Report (CER) is a comprehensive, heavily researched document that often delays the review process if not properly written. 

SECOND, obtain your ISO 13485 certification. If you’re seeking a CE mark for your device, then technically you should have already done this. In practice though, especially in the startup world, we know that sometimes certain processes can run faster than others, requiring efforts to catch up and backfill later. Now is the time to get this done.

THIRD, find an authorized representative. This is a person or an organization that will serve as a local contact for your device within the EU, a requirement under the Medical Device Regulation. If you do receive your CE mark, but haven’t yet started looking for an authorized representative, you’ll be dealing with avoidable delays as you prepare to release your device to market.

FOURTH, maintain contact with your Notified Body representative. In addition to keeping up with potential review dates, your rep can advocate on your behalf whenever the opportunity arises. If the Notified Body is trying to determine which class of devices they should focus on next, having someone nudge them to your device class can help get you on the review schedule sooner.  

If you start getting questions from your Notified Body looking to clarify details about your device, your quality system, your target regions, etc., then it likely means they’re trying to determine how many resources they’ll need for your technical file, and if they can fit you into the next batch of reviews. Clarifying questions often mean that it’s getting close to your turn.

Reach out to us if you would like to discuss your situation in more detail. We can help answer your questions and help prepare your technical file and quality systems for your Notified Body review.