What is the problem with MDR in the EU?

A recent publication on Notified Bodies Survey on certifications and applications [MDR/IVDR] with data from March 2023 from the European Commission showcases the following slide, which talks about MDR certificate #Refusals.

As many of you know, #EUMDR has had an unusual cycle of deadlines causing chaos. Small-scale manufacturers still don't know what deadline is applicable for their Medical Device.

With the ongoing chaos, this slide raises an alarm as

1. - Incomplete applications are being submitted
2. - Products are wrongly classified
3. - Applications are out of scope for some Notified Bodies
4. - Manufacturers are unable to keep up with communication from the Notified Bodies
5. - Problems with Quality Management Systems

While the notified bodies are increasing their capacities and resources, it is now upto the manufacturers to get the right resources in and build a robust compliance pathway for their medical devices.

The survey highlights that several manufacturers have pulled out from the process because of increased economic commitments. This is bound to happen as the certification and ISO 13485:2016 in itself is a time and money-consuming process. The latest audit costs are reaching a lifetime high. My colleagues at Med-Di-Dia Limited have seen that many companies do not plan their strategies effectively. In order to strengthen your regulatory and quality compliance activities, you must keep a check on certifications, technical files and quality processes. Some companies are asking that their technical files are reviewed and approved by one Notified Body whilst working with a different Notified Body to obtain ISO 13485:2016 certification.

Here it is important that companies:

• A.      Engage the same Notified Body to review their Technical File and also to audit their QMS for ISO 13485:2016 certification.
• B.      Before approaching any Notified Bodies for an audit, all documents are in place and the QMS has been operational for a period of at least 3 months.
• C.       Liaise with the Notified Body about their availability and capacity to take on new clients.

If the Notified Body does not have the capacity to review your technical files, then companies can approach another Notified Body.

In our case, the client was already going through an ISO 13485:2016 Audit by Notified Body A, who confirmed that they didn’t have the capacity to review the technical files. Since Notified Body A cannot review the technical files, the Company can contact a different Notified Body [Notified Body B] to undertake a Technical File Review. But … there is a catch!

If a Company has an ISO 13485:2016 certificate from one Notified Body [i.e. Notified Body A] but Notified Body A doesn’t have the capacity to review the Company's technical file(s), then the Company can approach another Notified Body [Notified Body B].

Notified Body B, however, will not accept the ISO 13485:2016 certificate from the first Notified Body [i.e. Notified Body A].  This is because hidden away in the EU Medical Device Regulation is the phrase ‘quality oversight’. Notified Bodies are interpreting this phrase ‘quality oversight’ as meaning that they must re-audit the QMS of the company because the ISO 13485:2016 certificate was awarded by a different Notified Body.  This re-audit of an already certified QMS (by Notified Body A) then ensures that Notified Body B meets their obligations under the EU Medical Device Regulation by having ‘quality oversight’. 

If a company is ‘caught’ in this scenario they will pay for Notified Body A to audit their QMS and provide them with an ISO 13485:2016 certificate and then pay Notified Body B to audit their already certified QMS so that Notified Body B can also review their Technical Files because Notified Body B now has ‘quality oversight’.  In this scenario, companies are facing a doubling of costs.

This is a good example of why MedTech companies must develop a robust regulatory strategy to ensure that costs are kept to a minimum and that they are able to do things “right first time”.. A “blind bull run” will only result in wasting time, resources and money.

Committing your financial resources to the wrong activities and tasks and walking on a misleading path will affect your sales and market entry cycle.

What should you do?

1. Consult the experts - There is no harm in connecting with experts who can pave the right path for your medical device compliance.
2. Get extra support - Your in-house RAQA teams could be overburdened. Apart from getting a valid MDR certificate, they are responsible for post-market vigilance and compliance requirements.
3. ACT NOW! - Further delays are going to increase the impact on your company and your patients. As MedTech professionals, all of us have commitments towards improving patient safety and enhancing the patient care process. Your device could be an essential element for someone.

At one stage, you will have to comply with the Regulations. All delays are only going to impact your company and patients.

Take a moment and THINK - What to do next?