A question and answer document has been published by the European Commission, the purpose of which is to facilitate the application of Regulation (EU) 2023/607
The main objective of the European Medical Device Regulation (MDR) 2017/745 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 regulations significantly strengthen key elements of the previous regulatory framework set out in Council and European Parliament Directives 90/385/EEC and 93/42/EEC.
To this end, manufacturers and notified bodies are given sufficient time to be able to carry out, in accordance with the MDR, conformity assessment of devices covered by a certificate or declaration of conformity issued under the old Directives 90/385/EEC and 93/42/EEC. In addition, the elimination of the “sell-off” period in the MDR and IVDR aims to prevent unnecessary disposal of safe devices.
This document does not exhibit exhaustive or complete information and may, therefore, be updated to respond to the emergence of new questions.
Which devices are eligible for the extended transition period?
Article 120, paragraph 2 (MDR) has been amended as follows; devices can be placed on the market until the stipulated dates:
- Dec. 31, 2027: for class III medical devices and class IIb implantable medical devices; except sutures, staples, dental fillings, orthodontic appliances, screws, wedges, plates, wires, pins, clips and connectors;
- Dec. 31, 2028: Class IIb (other than those mentioned above), IIa and I devices.
The extension will be granted only if the following requirements are met:
- 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;
- Adaptation of the quality management system;
- Submission and/or acceptance of the manufacturer’s application for conformity assessment to a notified body before May 26, 2024.
Are devices that have already been certified under the MDR extended transition period eligible?
Yes, provided that MDD/AIMDD certificates have not been withdrawn by the notified body. This means that a “previous device” and the corresponding MDR-compliant device can be placed on the market in parallel until the end of the relevant transition period.
Does the extended transition period also apply to custom-made devices?
Custom-made Class III implantable medical devices may be placed on the market until May 26, 2026 even in the absence of a certificate issued by a notified body for the conformity assessment procedure.
The necessary conditions for this to happen are:
- The submission of a formal application by the manufacturer/patron, by May 26, 2024, for the applicable conformity assessment;
- The signing of a written agreement between the authorized representative/manufacturer and the notified body (in accordance with Section 4.3, second paragraph, of Annex VII), by September 26, 2024.
How can the manufacturer prove that its previous device benefits from the extension of the transitional period?
The extension of the transitional period and the simultaneous extension of the validity of the certificate occur automatically by law, provided that the requirements of Article 120, paragraph 3 (MDR) are met. In line with MDCG Guide 2020-3,during the transitional period, notified bodies may not issue new MDD/AIMDD certificates.
However, they may provide written confirmation correcting or supplementing information on an existing certificate. It is recognized that the manufacturer may have to prove the validity of the certificate to third parties, for example, to gain market access in third countries.
To this end, manufacturers should have access to various means of demonstrating that their device is covered by the extended transition period and a valid certificate.
The manufacturer should be able to provide a self-declaration stating that the conditions for the extension are met, indicating the end date of the transition period.
This self-declaration could be based on a harmonized template and should clearly identify the devices covered by the extension and the certificates involved. Competent authorities should be able to issue certificates of free sale for the duration of the extended validity of the certificate.
The European Commission will update its fact sheets for competent authorities in non-EU/EEA countries, healthcare professionals and institutions, and the procurement ecosystem, explaining how the extended transition period works.
What is the meaning of “device intended to replace such device“?
The term “device intended to replace such device” is used in Article 120, MDR. A device intended to replace the previous device will usually (but not necessarily) differ from the previous device because the manufacturer has made significant changes to its design or intended purpose.
What evidence must the manufacturer provide for having implemented a quality management system in accordance with the MDR?
According to Article 120, paragraph 3 (MDR), the manufacturer must have in place a quality management system in accordance with Article 10, paragraph 9 (MDR) by May 26, 2024.
Manufacturers must prepare documentation on their quality system, which must be part of the application for conformity assessment. Compliance with the quality management system requirements regarding post-market surveillance, market surveillance, vigilance and registration are part of the appropriate surveillance under Article 120, paragraph 3e (MDR), while the conformity assessment (MDR) of the entire quality system will be carried out by the notified body as part of its conformity assessment activities.
Do manufacturers who submitted an application for conformity assessment and concluded a written agreement with a notified body before March 20, 2023, have to submit a new application and/or conclude a new written agreement?
No. Provided that the application has not been rejected.
What are the necessary elements of the agreement for the transfer of supervision from the notified body that issued the MDD/AIMDD certificate to the MDR notified body?
The written agreement referred to in Article 120(3) (MDR) and the agreement for the transfer of supervision concern different subjects. However, they can be combined into a single document depending on what is most convenient for the parties involved, such as when the notified body that issued the MDD/AIMDD certificate is not involved.
The agreement between the manufacturer, the outgoing notified body and the incoming notified body, a “tripartite agreement,” should also cover the possibility for the MDR notified body to suspend or withdraw a certificate issued by the MDD/AIMDD notified body where duly justified.
As stated in the third paragraph of Article 120, paragraph 3 (MDR), the incoming notified body does not assume responsibility for the conformity assessment activities performed by the notified body that issued the certificate.
In order to promote consistency among notified bodies, NBCG-Med, in consultation with NBO, could provide further clarification on a standard template for the tripartite agreement between the manufacturer, the MDR notified body, and the notified body that issued the Old Directive certificates.
Which notified body is responsible for carrying out appropriate surveillance when a written agreement under MDR Article 120(3c) is signed between the manufacturer and a notified body designated under the MDR?
Pursuant to Article 120, paragraph 3 (MDR), the notified body that issued the relevant certificate under the MDD/AIMDD shall continue to be responsible for carrying out appropriate surveillance in relation to the applicable requirements relating to the devices it has certified.
Alternatively, by September 26, 2024, the manufacturer may agree with a notified body designated under the MDR that the latter will become responsible for surveillance.
On September 26, 2024, the deadline by which the written agreement referred to in Article 120, paragraph 3 (MDR) must be signed, the notified body that has signed such an agreement will become responsible for appropriate surveillance.
If there is an agreement to transfer surveillance to another notified body designated under the MDR, what are the implications on labeling related to the notified body identification number?
Even when the appropriate surveillance is transferred to another notified body designated under the MDR, pre-existing devices can continue to be placed on the market and made available without changes to the labeling, including the CE marking, and thus indicate the number of the notified body that issued the certificate under the directive and that is kept valid.
However, if feasible in practice and based on the details included in the tripartite agreement, the manufacturer may decide to change the labeling of pre-existing devices by indicating the number of the notified body to which a formal application was submitted under the MDR.
Which devices will benefit from the removal of the “sell-off” period?
For both medical devices and in vitro diagnostics, the sell-off period, i.e., the end date for further making available devices/diagnostics that have already been placed on the market before or during the end date of the transition period, is deleted. This would eliminate unnecessary disposal of safe devices/diagnostics already placed on the market.
This means that medical devices that have been placed on the market before May 26, 2021 under the MDD/AIMDD or after May 26, 2021 during the transition period under Article 120 MDR (i.e., until December 31, 2027 or December 31, 2028, as applicable) can continue to be made available on the market without any limitation in time, subject to any shelf life or expiration date of the device.
Gruppo FarmaImpresa receives first MDR certifications
This achievement is so significant because we are among the first companies in Italy to have received MDR certifications for some of our substance-based medical devices.
The achievement is the result of a long work we have been doing for two years to ensure the compliance of our medical devices in order to proactively respond to regulatory changes and promote the success of our customers.
The medical devices for which we received the first certifications under MDR Class IIb are water or oil emulsions containing simethicone, in 6 different versions.
