MDCG 2022-18
The European Commission and the Medical Device Coordination Group (MDCG) came with some early holiday presents on December 9, 2022, it seems. But are these two items early Christmas presents? Let’s find out.
First, we need to split the two different news items:
Within the regulatory world, it has long been predicted that problems will arise when we approach May 2024. The shortage of designated Notified Bodies (NB) and the higher level of scrutiny of NBs are direct consequences of the proliferated requirements set out in the MDR. This predicted shortage of medical devices on the European market has now arrived in the mainstream news media. This has been a hot topic within the MDCG for a while now as can be seen by their publications over the past half year.
The series started in June with the publication of MDCG 2022-11 MDCG Position Paper: Notice to manufacturers to ensure timely compliance with MDR requirements. In this position paper, the MCDG basically said that manufacturers should focus on what they can do on their side to ensure compliance with the MDR because the MDR will not be extended. The apparent standpoint of the PMDCG is that there was enough guidance, and manufacturers have had enough time to comply with the MDR.
In August MDCG 2022-14 Transition to the MDR and IVDR - Notified body capacity and availability of medical devices and IVDs was published. In this paper, the MDCG came up with several measures intended to widen the bottleneck. These measures gave Notified Bodies the possibility to work more efficiently, with more access to Notified Bodies for manufacturers, and increased the preparedness of manufacturers.
The third publication in this series is the recently published 2022-18 MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate. This paper was published on the same day as the EPSCO meeting of December 9, 2022, after which big news was published. More about this later.
The MDCG 2022-18 guidance gives a short-term solution for manufacturers who are struggling to obtain a MDR certificate but work hard to get it or those who have a Notified Body that did not get the MDR designation yet. It highlights the possibilities of manufacturers in said situations. In article 97, provisions have been made that highlight the possibilities of manufacturers in said situations (for reference see below).
Before we celebrate, let’s see what the requirements are:
- Valid MDD/AIMDD CE certificate (or at least must have been valid at date of expiration)
- Devices which made use of Article 120(3) and are considered a legacy device acc to MDCG 2022-25
- Pro-actively inform your CA
- Recent and relevant PMS data must show safe and well performing device
- MDR compliant QMS
- Manufacturer should have undertaken reasonable efforts to transition to the MDR
- Application for conformity assessment accepted and signed by NB of the manufacturer
The period to fix the non-conformity should be in proportion with the level of the non-conformity but should not extend 12 months. This period can be extended in duly justified cases. Here one question arises, what is duly justified? And how long can this extension be? Also, what is a proportional amount of time to fix the non-conformity? About this, the guidance does not give any advice (yet?). Maybe the first revision will tell us more.
If there is any delay, the manufacturer should proactively notify the CA about the delay and the reason for the delay. It is good to see that the MDCG highlights this possibility which was already present in the MDR and gives some explicit guidelines on how to apply these articles. For all manufacturers who have expiring MDD/AIMDD certificates, I would suggest this route if you met the requirements.
Then there is the second big news update from December 9, 2022 – the draft proposal from the European Commission regarding the implementation of MDR. Several stakeholders have concerns that the measures proposed in the MDCG position paper 2022-14 will not suffice and request legislative measures which address the bottleneck more effectively. The following measures were proposed and accepted in the meeting.
⮚ An extension of the transitional period in Article 120(3) MDR with staggered deadlines depending on the risk class of the device.
⮚ If needed for legal and practical reasons (including access to third-country markets), the extension of the transitional period could be combined with an extension of the validity of certificates issued under Council Directives 90/385/EEC and 93/42/EEC by amending Article 120(2) MDR;
⮚ Conditions to be fulfilled in order to ensure that the extension applies only to devices that do not present any unacceptable risk to health and safety have not undergone significant changes in design or intended purpose and for which the manufacturers have already undertaken the necessary steps to launch the certification process under the MDR, such as adaptation of their quality management system to the MDR and submission and/or acceptance of the manufacturer’s application for conformity assessment by a notified body before a certain deadline (e.g. 26 May 2024); ⮚ The removal of the ‘sell off’ provision in Article 120(4) MDR and Article 110(4) IVDR.
(This gives the possibility to keep on selling MDD/AIMDD/IVDD devices (within their respective expiration date) that are already on the market. So, this is good news for the entire supply chain.)
At first glance, reading this it seems that this is good news. However, we must not forget that these measures are still in draft. So which points will be in the official version? What will the wording look like? It is still unknown how these measures will be implemented. What will the conditions of the third bullet point look like exactly?
Where all the above is intended to eliminate the bottlenecks but there is always the risk that they just actually postpone them.
Fingers crossed that the holiday period leads to a manufacturer-friendly version of the regulation. For now, enjoy the holiday season and take a short break. In the new year, you can pick up where you left off. Maybe in January we will have definite good news.
Article 97
1. Where, having performed an evaluation pursuant to Article 94, the competent authorities of a Member State find that a device does not comply with the requirements laid down in this Regulation but does not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health, they shall require the relevant economic operator to bring the non-compliance concerned to an end within a reasonable period that is clearly defined and communicated to the economic operator and that is proportionate to the non-compliance.
2. Where the economic operator does not bring the non-compliance to an end within the period referred to in paragraph 1 of this Article, the Member State concerned shall, without delay, take all appropriate measures to restrict or prohibit the product being made available on the market or to ensure that it is recalled or withdrawn from the market.
That Member State shall inform the Commission and the other Member States, without delay, of those measures, by means of the electronic system referred to in Article 100.
Links
Link to MDCG 2022-14: https://health.ec.europa.eu/system/files/2022-08/mdcg_2022-14_en.pdf
Link to MDCG 2022-11: https://health.ec.europa.eu/system/files/2022-06/mdcg_2022-11_en_0.pdf
Link to MDCG 2022-18: https://health.ec.europa.eu/system/files/2022-12/mdcg_2022-18_en_1.pdf
Link to the update regarding the state of play on the implementation of the Medical Device Regulations:
https://data.consilium.europa.eu/doc/document/ST-15520-2022-INIT/en/pdf