You will be aware from previous posts that industry has been concerned for some time about the amount of work to be done to ensure compliance with the Medical Devices Regulation (MDR), and whether this can be completed by May 2020, the date of application of the Regulation. However, so far, the Commission's response has been that the current deadline is "realistic and achievable" and that there were no plans to delay implementation.
This week, as an early Christmas present to industry, while there is no delay to the data of application of the MDR, there is some good news: a "corrigendum", or correction, to the MDR, has been approved by the Parliament that adds certain Class I devices to those devices that benefit from the transitional period under the MDR. This will give manufacturers of certain Class I devices additional time to comply with the Regulations.
Class I devices under the MDR
Under the original text of the MDR, Class I devices, which are placed on the market under the relevant Directive without the involvement of a notified body, had to comply with the provisions of the MDR by 26 May 2020. While the MDR contains transitional provisions to allow certain devices to continue to be placed on the market under the Directive past May 2020, these transitional periods only applied to devices that are placed on the market under a certificate of conformity issued by a notified body. As Class I devices are placed on the market under the self-certification declaration of the manufacturer, the transitional provisions did not apply.
On 25 November 2019, the European Parliament's Committee on Environment, Public Health and Food Safety (ENVI) voted on a corrigendum to the MDR. The corrigendum, now deemed to have been approved by the European Parliament as of 17 December, adds certain Class I devices under the Directive to those devices that benefit from the transitional period. Therefore, manufacturers of these types of Class I devices can continue to place these devices on the market under the Directive until May 2024, and the devices can continue to be made available to end-users until May 2025.
This change applies to Class I device under the Directive where:
- under the Regulation, the conformity assessment procedure requires the involvement of a notified body – software is a common example of devices that are "up-classified" in this way;
- a declaration of conformity was drawn up under the Directive prior to 26 May 2020; and
- from 26 May 2020, the device continues to comply with the Directive, and there are no significant changes in the design and intended purpose of the device.
This will come as good news to manufacturers of these Class I devices, which can now continue to be placed on the market for an additional 4 years. However, there are still aspects of these provisions that need to be clarified. For example, guidance will be beneficial on what is meant by "significant changes in the design and intended purpose of the device", and who will verify or monitor whether a certain change is significant.
There are further signs that the Commission is aware of difficulties in the MDR being applicable from May 2020. In November 2019, the Commission announced that the launch of the EUDAMED database will be delayed until 2022. The MDR foresees this delay, and states that if the development of EUDAMED is delayed, the obligations and requirements that relate to EUDAMED will apply six months after the publication of a notice that confirms that EUDAMED has achieved full functionality.
However, despite this delay to EUDAMED, the date of application of the MDR remains 26 May 2020, and manufacturers are required to comply with the MDR to the extent possible, and continue to comply with the provisions under the Directive on exchange of information until the new EUDAMED database is operational. How this will operate in practice, and whether there will be additional delays to EUDAMED, is not yet clear. In particular, given the wide variety of functions that EUDAMED was intended to provide, including vigilance reporting, registration of economic operators and information on the unique device identifier (UDI), the extent to which manufacturers can comply with these obligation, or whether Member States will implement national systems that carry out similar functions, will need to be clarified.
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