EU law on medical devices: New transition periods and other changes | In Principle

Amendments to the EU’s provisions on medical devices were published in the Official Journal on 9 July 2024. The new rules will begin to apply six months after publication (i.e. from 10 January 2025). In vitro diagnostic devices are gaining extended certificate validity and longer transition periods. The EUDAMED database can be launched in steps, which should speed up the mandatory use of the modules that are now ready. Meanwhile, manufacturers and other participants in the distribution chain have a new obligation to report problems with availability of medical devices.

Extending the validity of certificates for in vitro diagnostic devices

In March 2023, we reported on the extended certificate validity for medical devices. The new change now extends certificate validity for in vitro diagnostic (IVD) devices. EU lawmakers decided to grant IVD devices a similar privilege to that granted to other medical devices in 2023.

Currently, the IVD Regulation (2017/746) foresees that certificates for IVD devices issued under the old provisions, i.e. the IVD Directive (98/79), are to expire no later than 27 May 2025. The new rules will extend their validity until 31 December 2027, under certain conditions.

The extension will apply to certificates issued by notified bodies under the IVD Directive between 25 May 2017 and 25 May 2022 (i.e. the last day of application of the directive) which had not expired as of 26 May 2022 or been subsequently revoked.

The extension can be used only if all the following requirements are met:

• The devices continue to comply with the IVD Directive
• There are no significant changes in their design or intended purpose
• The devices do not present an unacceptable risk to the health or safety of patients, users or other persons, or pose other public health issues
• No later than 26 May 2024, the manufacturer has put in place a quality management system in accordance with the IVD Regulation
• No later than 26 May 2025, the manufacturer or authorised representative formally applies to a notified body in accordance with the IVD Regulation for a conformity assessment
• No later than 26 September 2025, the notified body and the manufacturer sign a written agreement in accordance with the IVD Regulation.

Additionally, if the certificates expired after 26 May 2022 but before 9 July 2024, the extension to 31 December 2027 will only be available if one of the following conditions is also met:

• Before expiration of the certificate, the manufacturer signed a contract for certification of the device under the new rules with a notified body, or
• A relevant state authority has granted permission to derogate from the need for a conformity assessment for the sake of patient welfare pursuant to Art. 54(1) of the IVD Regulation, or has required the manufacturer to carry out the relevant conformity assessment procedure pursuant to Art. 92(1) of the regulation.

New transition periods for in vitro diagnostic devices

The changes apply not only to IVD devices certified under the previous regulations, but also to IVD products that did not have to obtain certification from a notified body under the old provisions (or the IVD Directive), but must do so under the new provisions (IVD Regulation).

These are IVD products for which the declaration of conformity was issued before 26 May 2022. A conformity assessment involving the notified body issuing the certificate will not be required under these circumstances for:

• Class D products placed on the market or put into use by 31 December 2027
• Class C products placed on the market or put into use by 31 December 2028
• Class A and B sterile devices placed on the market or put into use by 31 December 2029.

However, these transition periods will be available only if all of the following requirements are met:

• The devices continue to comply with the IVD Directive
• There are no significant changes in the design or intended purpose
• The devices do not present an unacceptable risk to the health or safety of patients, users or other persons, or pose other public health issues
• No later than 26 May 2024, the manufacturer has put into place a quality management system in accordance with the IVD Regulation
• No later than 26 May 2025 (for a Class D device), 26 May 2026 (for a Class C device), or 26 May 2027 (for a Class B or Class A sterile device), the manufacturer or authorised representative has formally applied to a notified body in accordance with the IVD Regulation for a conformity assessment
• No later than 26 September 2025 (for a Class D device), 26 September 2026 (for a Class C device), or 26 September 2027 (for a Class B or Class A sterile device), the notified body and the manufacturer sign a written agreement in accordance with the IVD Regulation.

EUDAMED launched in stages

EUDAMED is a platform designed to collect data on medical devices. It will consist of six modules, with three of them now ready (registration of entities; registration of devices, treatment kits and UDI codes; notified bodies and certificates) and three still in development (market surveillance; observation and post-market surveillance; clinical trials and performance testing).

The rules previously stated that the individual modules would only become mandatory after all six modules were ready and deemed operational. The new change implies that fitness verification could be performed separately for each module, meaning that a given module could stand alone and start being mandatory before the process of creation of all six modules is completed.

Obligation to report supply problems

A new reporting obligation for device manufacturers has also been introduced. They must notify the supervisory authority (in Poland, the president of the Office for Registration of Medicinal Products) and their recipients of foreseeable disruptions in the continuity of supply (expected product shortages) if they could cause serious harm or a risk of serious harm to patients or public health in the EU.

The manufacturer must notify the authority six months in advance and include a justification (indicating the reasons for the interruption of supply). The regulator will then transmit the information to the European Commission and the authorities of other member states.

The manufacturer will also have to provide this information to its recipients (businesses, including authorised representatives, importers and distributors, as well as public health institutions or health professionals to whom the manufacturer directly supplies the product) six months in advance.

The six-month advance notice period does not apply to information on supply problems arising under exceptional circumstances.

In turn, recipients (e.g. distributors) have an obligation to promptly pass on the information on supply problems to their own recipients (the next links in the distribution chain to whom they directly supply the product).

Joanna Krakowiak, attorney-at-law, Marcin Rytel, adwokat, Life Sciences & Healthcare practice, Wardyński & Partners