COVID-19: MDR Postponement to may 2021

In light of the COVID-19 emergency, the European Commission has adopted the proposal to postpone the application of the medical device regulation (MDR) by one year.

On April 17, the European Parliament voted in favor of postponing the MDR due to COVID-19. It is now official, only the approval of Member States and publication in the Official Journal are pending.

The content of the amendment, in brief, is as follows:

Until 05/26/2021, medical devices of all classes can still be certified according to Directive 93/42/EEC. The directive will be repealed from 05/26/2021.

The new requirements for surveillance (plan, PSUR, report for class I), the person responsible for regulatory compliance, and UDI apply from 05/26/2021.

For non-medical products falling under Annex XVI, the MDR does not apply until the issuance of common specifications. The specifications will be adopted by 05/26/2021.

The specifications for reprocessing single-use devices will be published by 05/26/2021.

UDI on labeling and packaging: class IIa and IIb from May 26, 2023, class I from May 26, 2025, class III and implantables May 26, 2021 (unchanged).

The Details of the Changes

The postponement proposal refers to the sections of the regulation without detailing the subject matter. For simplicity, I report the main changes in their context:

Article 1

The necessary common specifications (for products in Annex XVI that do not have a medical purpose, ed.) shall be adopted by May 26, 2020 May 26, 2021. They shall apply from six months after the date of their entry into force or from May 26, 2020 May 26, 2021, whichever is later.

Article 17

The article deals with the reprocessing of single-use medical devices to be carried out in accordance with common specifications (CS).

The Commission shall adopt […] the necessary CS […] by May 26, 2020 May 26, 2021. […].
If the CS are not adopted by May 26, 2020 May 26, 2021, reprocessing shall be performed according to relevant harmonized standards and national provisions […].
Only single-use devices that have been placed on the market in accordance with this Regulation or, before May 26, 2020 May 26, 2021, in accordance with Directive 93/42/EEC may be reprocessed.

Application of Article 59

The article concerns the possibility of placing certain medical devices without CE marking on the market. At the date of publication of the draft in our possession, this article will be valid until May 25, 2021. The products concerned are and will be indicated by the competent national authority.

Article 113

Member States shall lay down the rules on penalties applicable for infringement of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. […]. Member States shall notify the Commission of those rules and of those measures by February 25, 2020 February 25, 2021 […].

(Considering that the deadline had already passed anyway, it’s clear that no state had already taken action on this matter, ed.)

Article 120

From May 26, 2020 May 26, 2021, any publication of a notification in respect of a notified body in accordance with Directives 90/385/EEC and 93/42/EEC shall become void.
Devices lawfully placed on the market pursuant to Directives 90/385/EEC and 93/42/EEC prior to May 26, 2020 May 26, 2021, and devices placed on the market from May 26, 2020 May 26, 2021 by virtue of a certificate (according to 93/42/EEC in force, ed.), may continue to be made available on the market or put into service until May 27, 2025 May 26, 2025 (the year doesn’t change, ed.).
By way of derogation from Directives 90/385/EEC and 93/42/EEC, devices which comply with this Regulation may be placed on the market before May 26, 2020 May 26, 2021.
[…] those Directives (93/42/EEC and 90/385/EC, ed.) are repealed with effect from May 26, 2020 May 26, 2021.

Article 123

It (Regulation 2017/745, ed.) shall apply from May 26, 2020 May 26, 2021.
[…] where, due to circumstances […] Eudamed is not fully functional on May 26, 2020 May 26, 2021, the obligations and requirements that relate to Eudamed shall apply from the date corresponding to six months after the date of publication of the notice […].
Article 27(4) (affixing UDI on labeling and packaging, ed.) shall apply to class IIa and IIb devices from May 26, 2023 and for class I devices from May 26, 2025.

(For implantables and class III, what is currently in the Regulation remains valid: for implantable devices and for class III devices […], it shall apply from May 26, 2021).

For reusable devices that bear the UDI carrier on the device itself, the UDI shall be affixed to the label and packaging from two years after the dates referred to in the point above.

Further Postponements

To complete the picture related to the implementation dates, we have recently also seen an amendment for adjusting the transitional period for class I devices that change class and require the involvement of the notified body. In this case, a one-year postponement of the indicated dates is not foreseen.