The Medical Devices Regulation (MDR) represents a major overhaul of the regulatory framework for medical devices in Europe. It replaces the Medical Device Directive (MDD) that has been in place since 1993. All products that were certified under MDD will require re-certification under MDR, and many devices will be up-classified, including devices that did not previously fall within the scope of MDD.

The transitional period

The MDR provides for a transitional period, which will allow manufacturers of medical devices to ensure that their product remains on the market in order to meet patient needs. In addition, the implementation date for the MDR has been extended from 26 May 2020 to 26 May 2021, due to concerns that the COVID-19 pandemic could delay manufacturer’s readiness.

Consequently, manufacturers of qualifying Class I medical devices that have a Declaration of Conformity (DoC) issued under MDD prior to 26 May 2021 can continue to place the product on the market until 26 May 2024 (the conditions to avail of the transitional period are set out below). We examine the transitional provisions under MDR in conjunction with recently revised Medical Device Coordination Group guidance[1] (MDCG Guidance) on those transitional provisions, which was issued in July 2020.

MDCG Guidance

The revised MDCG Guidance was issued to provide guidance for manufacturers of Class I devices that are required to have certificates after 26 May 2024, on the information that must be included in the DoC.

Conditions that must be met in order to enjoy transitional period

Under Article 120(3) of the MDR, some Class I devices under the MDR may continue to be placed on the market or put into service until 26 May 2024, and may continue to be made available or put into service until 26 May 2025. The necessary conditions to enjoy the transition provisions are:

1. The device must continue to comply with its MDD requirements

2. A notified body will need to be involved under the MDR, e.g. in the case of up-classified devices

3. A valid DoC must be issued prior to 26 May 2021

4. No significant changes to the design or intended purpose of the device may be made after 26 May 2021, and

5. The MDR requirements relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices will apply in place of the corresponding MDD requirements from 26 May 2021

Content of a valid DoC

Class I medical devices are required to self-certify. The DoC is a declaration by the manufacturer of a Class I device, or their authorised representative, that the product has undergone the required conformity assessment procedure and that it meets the MDD requirements.

The DoC must contain the following:

• A number identifying the product, e.g. a product, batch, type or serial number, and the manufacturer has discretion in this regard

• The name and address of the manufacturer or their authorised representative issuing the declaration

• A statement that the declaration is issued under the sole responsibility of the manufacturer

• The identification of the product that will allow traceability

• Evidence that all EU harmonisation legislation has been complied with, i.e. ISO or other national technical standards must be referenced in precise and clearly defined way (to include the version/date of the relevant standard)

• The name and identification of the notified body, and the reference to the relevant certificate, if applicable

• Any supplementary information that may be required, e.g. the category, and

• The date of issue of the declaration, signature and title of the authorised person.

The EC guidance highlights that the date of issue of the DoC can be any date after the conformity assessment, but it must be prior to 26 May 2021.

Maintaining the DoC

Manufacturers must keep the DoC for at least five years after the last product has been manufactured, and it must be made available on request by the competent authorities. Any changes to the DoC must be recorded, and a record must be kept of the date of the change. The DoC and the corresponding technical documents should allow the manufacturer to show that the DoC was lawfully issued before 26 May 2021, and that there are no significant changes in the design or intended use. We have previously written about the meaning of “significant changes”, which can be accessed here.

Conclusion

Manufacturers of Class I medical devices under MDD may continue to place devices on the market after the implementation of MDR in certain cases, provided the requirements as set out in Article 120 are met and provided that a DoC has been issued before 26 May 2021. The grace period will allow manufacturers time to re-classify their product under MDR so that they can place their product on the market after the expiry of their MDD certificate.

The transitional measures allow manufacturers to prepare for the MDR and to ensure that patients are not suddenly left without a necessary medical device on the implementation of MDR.

For more information on complying fully with the various requirements of the MDR, contact a member our Product Regulation & Consumer Law team.