Regulatory backlog: why medical device manufacturers should not delay MDR implementation

Since the Medical Device Regulation (EU) 2017/745 (MDR) finally came into force last May, many manufacturers have been faced with the challenge of meeting the more stringent requirements for medical devices and legacy devices. The transition period for manufacturers currently runs until May 2024.

Facts and figures

25254 expiring MDD/AIMDD certificates are compared to 27 (Medical Journal of 10.02.2022) notified bodies (Notified Bodies) according to EU Regulation 2017/745, 2017/746.
In 2021 and 2022, 2747 MDD/AIMDD certificates will expire, in 2023 another 4570 MDD/AIMDD certificates will expire and in 2024 there will be 17937.
In September 2021, only 3920 applications for MDR certification were submitted to the notified bodies and only 502 MDR certificates were issued.

A certification backlog is therefore to be expected for 2023 and 2024.

Without a quick solution to the current bottleneck at the Notified Bodies and the massive certification backlog still to be expected, serious economic consequences for the medical device industry are to be expected, i.e. new medical devices cannot be brought to market promptly and existing and proven medical devices may not be “converted” to MDR in time and therefore not be made available to patients.

However, even if this is not due for another two years, manufacturers should not hesitate to implement the MDR requirements.

There are several reasons for this, because the workload for Notified Bodies has also increased enormously due to the new MDR. Challenges arise in different areas, because:

Lack of capacities at the Notified Bodies
Capacity problems and bottlenecks at the Notified Bodies are already evident today. This is because they also have to check the approval of a medical device in accordance with more stringent regulations. However, the number of MDR-certified notified bodies is small, resulting in an overload and long waiting list.
MDR certification of new Notified Bodies stalls
To prevent capacity problems, the European Commission announced the certification of 20 new Notified Bodies by 2019 – an elaborate and lengthy procedure. The EU Commission failed to meet this target, which, among other things, exacerbated the capacity problems.
Guidelines and specifications are not finalised
Central guidelines for the implementation of the MDR requirements are not yet available and MDCG guidelines to assist in the implementation of the requirements are also not yet finalised. The final version of the EUDAMED is also not yet fully accessible for manufacturers.
Finding the right Notified Body
Medical devices may only be audited by Notified Bodies that have been designated for this purpose. This means that manufacturers do not have the option of undergoing the approval procedure at any Notified Body, but are limited to a few. This also exacerbates capacity bottlenecks.

For the years 2023 and 2024, the EU Commission and European associations (industry association and association of notified bodies) see even greater capacity problems ahead for Notified Bodies. An approval and certification backlog, which may reach a peak especially in the next two years, is the consequence. This is because even though the introduction of the Medical Devices Regulation (EU) 2017/745 was delayed due to the Corona pandemic, further transition periods have not been extended.

Thus, Notified Bodies are facing an increased workload and unprocessed marketing authorisation applications, while at the same time manufacturers are facing the pressure of the impending marketing authorisation backlog.

Good to know

Class I medical devices currently benefit from the transition period until May 2024 if no certificates have been issued by Notified Bodies for them and they are subject to a higher classification according to MDR.

According to MDR (Article 120(3)), medical devices with a valid certificate are also subject to the requirement. Only after the expiry of the certificate or the end of the transitional period is the conformity assessment procedure necessary.

Start MDR implementation

It is therefore important for manufacturers not to delay the implementation of the MDR requirements. We support you in your project. As a legal manufacturer, the BAYOOCARE team specialises in the preparation and maintenance of declarations of conformity for medical devices.

From regulatory affairs and quality assurance measures to post-market surveillance – together we will bring your medical device to market in accordance with the MDR.

We will be happy to advise you on your project. Please contact us for a no-obligation consultation.

Regulatory backlog: why medical device manufacturers should not delay MDR implementation

Facts and figures

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