Why You Need To Get MDR Certification In 2023

July 5, 2022

4 mins

EU MDR EU IVDR

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If your plan was to wait until 2023 to leisurely address compliance with the Medical Device Regulation (MDR 2017/745) and obtain new MDR certification, here’s some new information that may light a fire under you.

Everyone is planning on doing the same thing…

For a more updated version of this regulation please visit this link.

Getting your MDR certification sooner than later

Many manufacturers are proudly sitting on a valid CE certificates issued in compliance with the old Medical Devices and Active Implantable Directives (MDD/AIMDD). Many of those certificates are valid right up until May 26, 2024.

In April 2022, Team NB (European Association for Medical Devices of Notified Bodies) conducted a survey of its members. Buried on page 33 of an otherwise mundane PowerPoint presentation was a chart that made everyone who knows anything about the MDR/IVDR sit up straight in their office chair. See below.

MDD, IVDD and AIMDD certificates are expiring

* Remember that 80-85% of IVDs will now require Notified Body involvement, up from 10-15% now. The numbers above only reflect IVDD certificates, not all of the new IVDs that will require IVDR certification.

Yes, that means 70% of all MDD, IVDD and AIMDD certificates expire during the first 5 months of 2024. Team NB estimates that their members can only issue about 6,300 certificates per year. When you combine the impending avalanche of MDR certificates with the need for IVD manufacturers to get started on their IVDR applications, it’s not hard to visualize the many tears that will be shed by regulatory managers who wait too long to schedule an MDR or IVDR audit with their Notified Body.

Plan on your MDR certification taking more time than you expect

The Team NB survey also notes that half of all submitted technical documentation is deemed incomplete and requires additional information before an assessment can begin. Even if your meticulously prepared application passes the completeness check, be prepared to wait. Roughly 53% of new MDR certificates currently take 12-24 months to issue, and less than 5% are issued in less than 6 months.

Notified Bodies will just hire more people, right?

We can hope so but it’s not like qualified regulatory professionals with knowledge of the new regulations are roaming the streets with no other job prospects. Notified Bodies (NB) – like all medical device and IVD manufacturers and consultancies – are feverishly trolling for talent like you. Once a Notified Body reels in a prospect, it takes a long period of training to get them up to speed. The members of Team NB did boost their full-time employee and contractor headcount by 42% in 2021 compared to 2020 but it remains to be seen if that will be enough to handle the impending crush. Today there are 29 NBs designated under the MDR, with the potential for an additional 7 to be added, However, given that the big players are already designated, this will not dramatically reduce the pending backlog.

MDCG warns medical device manufacturers

Even the Medical Device Coordination Group (MDCG) felt the need to warn medical device manufacturers about the impending crunch in this unusual document. Therein they casually state: “In this context, it is expected that the manufacturer has submitted an application to a notified body for certification in compliance with the MDR at least one year before the expiry date of the MDD/AIMDD certificate.”

One year is the minimum. The end game here is that you should get your MDR/IVDR house in order as soon as possible. You can get a leg up on your competition by getting MDR or IVDR-certified well before your existing certificates expire. The scramble for Notified Body attention will only get worse in 2023 and Notified Bodies may stop accepting new MDR applications sometime later in 2023 or even earlier, as we have heard. Don’t wait. Initiate the necessary processes to transition your devices from the MDD or AIMDD sooner rather than later.