MDCG 2022-11 Rev 1: Urgency for MDR and IVDR Compliance

On 30 November 2023, the Medical Device Coordination Group (MDCG) issued a revised guidance document, MDCG 2022-11 Rev 1. This revision added one new section to the guidance (Call to notified bodies to streamline the certification process) and modified an existing section (Call to manufacturers to transition to the Regulations and submit their applications for certification without further delay).

The MDCG document also includes a set of graphs detailing the number of applications and certificates issued from February 2021 to June 2023 for In Vitro Diagnostic Regulation (IVDR) and Medical Device Regulation (MDR) Quality Management System (QMS) Certificates (Annex IX Chapter 1, Annex XI Part A), as well as MDR Product Certificates (MDR Annex IX Chapter II, Annex X, Annex XI Part B). This indicates that only approximately 50% of IVDR and 25% of MDR certificates have been issued based on the number of applications made.

Figures on the number of overall applications for MDR/IVDR in comparison to the number of Medical Devices Directive (MDD), Active Implantable Medical Devices Directive (AIMD) and In Vitro Diagnostic Medical Device Directive (IVDD) certificates are also included. There are approximately 24,000 certificates issued under the MDD/AIMD, while only 13,000 applications have been made for MDR. The situation is more concerning for IVDs. Approximately 1,100 IVDR applications have been made, compared to 1,500 IVDD issued certificates. However, while only 8% of IVDs needed certification under the IVDD, about 80% of IVDs now require certification under the IVDR.

The figures above highlight why Revision 1 of the MDCG document has been issued.

The revised MDCG document covers several significant points. These are highlighted below, divided into the two newly referenced or modified areas.

Call to Notified Bodies to Streamline the Certification Process

1. Notified Bodies must make all efforts to streamline their processes and improve their activities in the areas of transparency, timelines, predictability and consistency. In particular, Notified Bodies should consider the particular requirements of Subject Matter Experts (SMEs) in the area of fees.
2. Notified Bodies should aim to offer assistance to manufacturers with Regulatory Guidance and Technical issues. This should hopefully ensure a smoother application process and avoid incomplete applications (one of the main reasons for delays in the process). This process should be conducted via “structured dialogues” between the Notified Body and manufacturer, which must be part of the normal pre-application and conformity assessment activities and not a separate charged service (e.g., consultancy).
3. The MDCG has requested that Notified Bodies regularly supply information on the number of applications and issued certificates.
4. The MDCG finally calls on Notified Bodies to increase transparency around their capacity and timelines for conformity assessment and to make publicly available, ideally on a common website, specific information on capacity available at each Notified Body across the EU for both MDR and IVDR.

 

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NAMSA Experts Weigh In

Although the objective of the comments are clear, Point 4, seems particularly unlikely to occur, given that Notified Bodies are commercial enterprises that compete with each other. Therefore, it is doubtful commercially sensitive information such as capacity and timeline information will be shared between Notified Bodies, or be made publicly available.

There is also no indication from MDCG that they would facilitate the requested common website. It is very unlikely that Notified Bodies will add additional costs to their operations by setting up and maintaining the website before issues of commercial confidentiality are even considered.

The main issue for Notified Bodies is primarily capacity and the need to find suitably qualified personnel to undertake their activities. In practice, presently, the number of suitably qualified personnel are not available to meet the needs of all Notified Bodies. This issue is further exacerbated by the increased competency and experience requirements necessary under the MDR/IVDR.

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Call to Manufacturers to Transition to the Regulations and Submit Their Applications for Certification without Further Delay

1. Manufacturers should remember that the application and certification process under the new regulations is considerably longer than under the previous directives. One of the main reasons for this delay is incomplete application documentation from manufacturers. MDCG manufacturers should make the best possible use of the extensions to both the MDR and IVDR by submitting complete and accurate applications in a reasonable time.
2. Manufacturers are asked to transition their certification to the new regulations as soon as possible and not to delay submissions any further. Specific reference is made to IVDR Class D devices, which must transition to the IVDR by May 2025, with Notified Bodies having recommended applying before the end of 2023.
3. Again, the MDCG has requested that manufacturers regularly supply information regarding their devices and work closely with the authorities to increase transparency on specific medical devices to allow time to prepare for changes to product ranges.

 

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NAMSA Experts Weigh In

The intention of the comments above are clear. However, as with the request for increased transparency for Notified Bodies, there is no indication of how or who will obtain the information required in Point 3.

The main message of the MDCG for manufacturers is to stop any further delay and to get their MDR/IVDR applications in as soon as possible. Waiting to submit applications until closer to the extended deadlines will cause bottlenecks and capacity problems down the line, especially considering that it is unlikely any further extensions will be granted.

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The publishing of this MDCG document acknowledges that there are still significant issues related to the implementation of the MDR/IVDR. The revised MDCG does not add any new pragmatic recommendations but is an exaltation to both Notified Bodies and manufacturers to speed up the application process.

However, the fundamental issue of an overall lack of resources and experience in medical device regulation, particularly within Notified Bodies, will remain exacerbated by the increased requirements in the new regulations. It remains to be seen whether these exaltations are sufficient or if further actions will be required in the future.

How Can NAMSA Help?

NAMSA has a dedicated team of regulatory and clinical specialists, comprising of former Notified Body staff and experts, to help you successfully achieve MDR and IVDR compliance and certification. To learn about NAMSA’s full suite of Regulatory services and solutions, including MDR and IVDR compliance planning, please visit: https://namsa.com/services/regulatory-and-quality-consulting/.

If you are interested in scheduling a complimentary consultation with one of our EU MDR or IVDR experts, we invite you to do so at https://namsa.com/locations-contact/.