Question and Answer
When do the Regulations apply?
The medical devices Regulation (MDR) (2017/745/EU) will apply from 26 May 2021 and the in vitro medical device Regulation (IVDR) (2017/746/EU) will apply from 26 May 2022 – the respective Dates of Application (DoAs).
Some provisions of these Regulations will apply earlier (e.g. regarding Notified Bodies and the Medical Device Coordination Group). Some will apply later (e.g. Unique Device Identification and labelling).
When do the existing Directives cease to apply?
In general, Directives 90/385/EEC and 93/42/EEC will be repealed with effect from 26 May 2021, and Directive 98/79/EEC will be repealed with effect from 26 May 2022. However, there are some exceptions, such as – for the continued marketing of devices that comply with the Directives (see below); and to serve as a backup in case EUDAMED is not fully functional by the DoA.
What is the applicable legislation up to the respective DoA?
Until the DoA, the laws and regulations adopted by Member States in accordance with the Directives will continue to apply. However, there are some exceptions.
Is it possible to place devices on the market that are compliant with the Regulations prior to the DoA?
Yes, manufacturers may place compliant devices on the market before the end of the transitional period. This applies to devices in all risk classes, and includes, for example, custom-made devices, systems and procedure packs.
Medical devices that are subject to the clinical evaluation consultation procedure according to MDR Article 54, and IVD Class D devices according to IVDR Article 48(6), may not be placed on the market before the expert panels have been established.
Depending on the risk class of the device, conformity assessment may involve an appropriate Notified Body. This requirement may create further delays before such devices can be placed on the market.
Which obligations of the Regulations do manufacturers need to fulfil in order to place compliant devices on the market before the DoA?
Manufacturers should meet as many obligations as possible, bearing in mind that the complete MDR/IVDR infrastructure, including EUDAMED, may not be fully functional before the respective DoA.
Both the device and the manufacturer must comply with the Regulations. Manufacturers should undertake an assessment of the conformity of their device.
Medical devices that are subject to the clinical evaluation consultation procedure according to MDR Article 54, and IVD Class D devices according to IVDR Article 48(6), may not be placed on the market before the expert panels have been established.
Depending on the risk class of the device, conformity assessment may involve an appropriate Notified Body. This requirement may create further delays before such devices can be placed on the market.
Do certificates issued by Notified Bodies under the existing Directives remain valid after the DoA?
Yes, certificates will generally remain valid until the end of the period indicated on the certificate, or until 26 May 2024, whichever is the earlier. On 27 May 2024, certificates issued under the Directives will become void.
Can manufacturers still place on the market/put into service Directive-compliant devices after the end of the transition period?
Yes, under certain conditions there will be an option to continue placing on the market/putting into service devices that comply with the Directives, until their existing certificates expire. This may avoid the immediate need for a new certificate under the Regulations.
To use this option, all the existing certificates will have to be valid (including, for example, the QMS), the purpose and nature of the device must not change, and manufacturers must apply the new requirements with regard to registration, surveillance and vigilance.
What is the “sell-off” provision about?
The “sell-off” provision is intended to limit the time during which devices that are compliant with the Directives and have already been placed on the market may be made available.
Any devices that are still within the supply chain and that have not reached their final user as being ready for use, for example a hospital, on 26 May 2025 are no longer marketable and must be withdrawn.
Once a Directive-compliant device has been made available to the final user by the deadline, the further making available of this device is not subject to the Regulations.
Article 11 - Authorised Representative
Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorised representative.
The designation shall constitute the authorised representative’s mandate, it shall be valid only when accepted in writing by the authorised representative and shall be effective at least for all devices of the same generic device group.
- The authorised representative shall perform the tasks specified in the mandate agreed between it and the manufacturer. The authorised representative shall provide a copy of the mandate to the competent authority, upon request.
The mandate shall require, and the manufacturer shall enable, the authorised representative to perform at least the following tasks in relation to the devices that it covers:
- verify that the EU declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer;
keep available a copy of the technical documentation, the EU declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements, issued in accordance with Article 51, at the disposal of competent authorities for the period referred to in Article 10(7);
comply with the registration obligations laid down in Article 28 and verify that the manufacturer has complied with the registration obligations laid down in Article 26;
in response to a request from a competent authority, provide that competent authority with all the information and documentation necessary to demonstrate the conformity of a device, in an official Union language determined by the Member State concerned;
forward to the manufacturer any request by a competent authority of the Member State in which the authorised representative has its registered place of business for samples, or access to a device and verify that the competent authority receives the samples or is given access to the device;
cooperate with the competent authorities on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices;
immediately inform the manufacturer about complaints and reports from healthcare professional’s patients and users about suspected incidents related to a device for which they have been designated;
terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation.
- The mandate referred to in paragraph 3 of this Article shall not delegate the manufacturer’s obligations laid down in Article 10(1), (2), (3), (4), (5), (6), (8), (9), (10) and (11).
Without prejudice to paragraph 4 of this Article, where the manufacturer is not established in a Member State and has not complied with the obligations laid down in Article 10, the authorised representative shall be legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer.
An authorised representative who terminates its mandate on the grounds referred to in point (h) of paragraph 3 shall immediately inform the competent authority of the Member State in which it is established and, where applicable, the notified body that was involved in the conformity assessment for the device of the termination of the mandate and the reasons therefor.
Any reference in this Regulation to the competent authority of the Member State in which the manufacturer has its registered place of business shall be understood as a reference to the competent authority of the Member State in which the authorised representative, designated by a manufacturer referred to in paragraph 1, has its registered place of business.