EPSCO meeting: commission discussed the future of medical devices
With the adoption of the European Medical Device Regulation (MDR) 2017/745, the regulation for medical devices has changed dramatically.
The main goal of the MDR (Medical Device Regulation) is to “establish a robust, transparent, predictable and sustainable regulatory framework for medical devices, ensuring a high level of safety and health, while supporting innovation.”
The concern is that there will be a shortage of essential medical devices in the future.
During the EPSCO meeting, the Commission discussed the future of medical devices.
Following the meeting in the form of MDCG 2022-18, the position paper on the implementation of Article 97 of the Medical Device Regulation (MDR) was released.
The broad outlines of the proposals provided by the Commission include an extension of the transition period under Article 120(3) MDR beyond May 26, 2024 for medical devices falling under the scope of the aforementioned with staggered expiration according to the risk class of the device (provisional dates):
- Class III and IIb: 2027;
- Class IIa and I: 2028.
For legal and practical reasons, the extension for the interim period could be combined with the extension of the validity of certificates issued under Council Directives 90/385/EEC and 93/42/EEC by amending Article 120(2) MDR.
There are, of course, conditions to be met for the activation of the extension, such as:
- Medical devices that do not present unacceptable health and safety risks;
- Medical devices that have not undergone significant changes in design and/or intended use;
- Medical devices for which manufacturers have already undertaken the necessary steps to initiate the MDR certification process, such as:
- adjustment of the quality management system;
- subm and/issionor acceptance of the manufacturer’s application for conformity assessment to a notified body before May 26, 2024.
As a result, the extension will only apply to those who have adapted their quality management system and/or submitted the manufacturer’s application for conformity assessment to a notified body before May 26, 2024.
But the criteria established for the extension are still very vague and not well defined.
If the extension criteria were based only on point two (submission and/or acceptance of the manufacturer’s application for conformity assessment to a notified body before May 26, 2024), this would not solve the problem faced by notified bodies, which is lack of manpower. If, on the other hand, the extension criteria were based solely on point two (the adaptation of the quality management system), what assessments will be carried out in order to determine whether the quality system is adequate?
Will an extension of the transition period, then, be formalized?
Unfortunately, not yet. The Commission will formally submit the proposal in early January 2023.
MDCG position paper for Article 97
Previous MDCG position papers 2022-11 and 2022-14 mentioned measures related to Article 97.
MDCG Position Paper 2022-18 legally introduces nothing new, since, the use of Article 97 has always been present in the MDR and available to member states that wanted to use it.
Let us recall what Article 97 says:
Where, after carrying out an evaluation in accordance with Article 94, the competent authorities of a Member State find that the device does not comply with the requirements of this Regulation but does not present an unacceptable risk to health and safety, they shall require the relevant economic operator to put an end to the non-compliance in question within a reasonable period of time, clearly defined and communicated to the economic operator, commensurate with the non-compliance.
Where the economic operator does not bring the non-compliance to an end within the period of time referred to in paragraph 1 of this Article, the Member State concerned shall immediately take all appropriate measures to restrict or prohibit the product’s being made available on the market or ensure that it is recalled or withdrawn from the market. That Member State shall as soon as possible inform the Commission and the other Member States of such measures by means of the electronic system referred to in Article 100.
In order to ensure the uniform application of this Article, the Commission may, by means of implementing acts, specify appropriate measures to be taken by competent authorities to counter certain types of non-compliance.
The big takeaway from MDCG position paper 2022-18 is that member states will recognize decisions, in the MDR field, issued by other member states under Article 97(1). This means that one application will suffice for the entire territory of the Union.
To whom and how will it be possible to apply Article 97?
In this case, MDCG position paper 2022-18 provides the following conditions:
- Application in the member states of the manufacturer or its authorized representative;
- No unacceptable risk to public health and safety;
- No non-compliance other than certificate expiration;
- Limited temporary exemptions: The competent authority defines the duration of the exemption, which is usually 12 months, extendable in duly justified cases.
But what is meant by duly justified cases?
– The manufacturer is an SME;
– The MDD or AIMDD certificate, of that SME manufacturer, has been issued by a notified body, not yet, designated under MDR;
– The SME manufacturer can demonstrate that it made reasonable efforts to submit the application to multiple notified bodies and that its application was not accepted due to the limited capacity of the notified body.
– The device shall not be subject to changes in labeling, including CE marking.
This procedure will also be available to manufacturers with certificates that have already expired.
MDCG position paper 2022-18 also states that certificates of free sale can still be issued in accordance with local regulations with a validity that should not exceed the period within which the medical device should be compliant according to MDR.
There are essentially two unknowns:
1. How does MDCG position paper 2022-18 relate to the Commission’s proposal to extend the terms of Article 120?
2. In order to obtain a waiver from Article 97 MDR, one has to prove that the medical device is indispensable for public health and that there are no alternatives on the market, which is not easy to prove in practice.
So we will have to wait until early January 2023 for the final proposal from the Commission to best understand how to proceed.
Are you a manufacturer or distributor and don’t know how to submit an application for certification under MDR?
