Yesterday, the Environment, Public Health and Food Safety Committee of the European Parliament approved a corrigendum to the EU Medical Device Regulation (EU MDR), which provides a four-year ‘grace period’ for class I medical devices which are up-classified by the EU MDR.
We understand that this still needs to be voted on and published following the December plenary session of the European Parliament, but we do not anticipate any changes (we will of course update this note if there are).
The original text of the EU MDR prohibited a manufacturer of an up-classified class I device (requiring assessment by a notified body for the first time under the EU MDR) from placing on the market their Medical Device Directive (MDD)-compliant device after 26 May 2020. As discussed in our previous articles, given the dearth of notified bodies, this created the very real prospect of a market shortage of affected devices (including whole classes of device such as software, which are particularly impacted by up-classification).
The corrigendum approved yesterday seeks to address this. It amends Article 120(3) to read as follows (with the new text underlined):
“By way of derogation from Article 5 of this Regulation, a device which is a class I device pursuant to Directive 93/42/EEC, for which the declaration of conformity was drawn up prior to 26 May 2020 and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body, or which has a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and that is valid by virtue of paragraph 2 of this Article, may be placed on the market or put into service until 26 May 2024 provided that from 26 May 2020 it continues…”
In our view, the provision is easier to read if it is paraphrased as follows:
‘By way of derogation from Article 5 of this Regulation, a device which:
- is a class I device pursuant to the MDD, for which the declaration of conformity was drawn up prior to 26 May 2020 and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body, or
- has a certificate that was issued in accordance with the AIMDD or MDD and that is valid by virtue of paragraph 2 of this Article, may be placed on the market or put into service until 26 May 2024 provided that from 26 May 2020 it continues to comply with either of those Directives, and provided there are no significant changes in the design and intended purpose…
The change means that a device which was CE marked (where the declaration of conformity etc. was drawn up) as a class I device under the MDD before 26 May 2020, which now requires a notified body for the first time under the EU MDR, could continue to be placed on the market or put into service for the first time after 26 May 2020 until 26 May 2024. Essentially, this provides a four year extension for up-classified class I MDD devices to be placed on the market. This will afford much more time to obtain a declaration of conformity in accordance with the MDR requirements.
In addition, once placed on the market, these devices can continue to be made available or put into service subsequently (such as by distributors) until 26 May 2025 in accordance with Article 120(4) – an additional year. As a minor note, this date was originally 27 May 2025, but the corrigendum also amends this.
Certain EU MDR provisions will apply to devices availed of the extensions under Article 120(3) and 120(4). For example, provisions regarding post-market surveillance, vigilance and registration (once EUDAMED is in place). In addition, no significant changes can be made to the intended purpose and design of relevant device post-26 may 2020. Subject to those requirements, the corrigendum (and initial drafting of Article 120(4)) effectively provide for the continued availability of up-classified class I MDD devices for at least four years. We do emphasise, however, that the declaration of conformity etc. for these products must be made in accordance with the MDD before 26 May 2020, otherwise these provisions do not apply.
As an interesting aside, we understand that during the vote on the corrigendum, an MEP raised a concern that the corrigendum was being used to introduce substantive changes to the legislation. The MEP considered this to be incompatible with the purposes of corrigenda within the EU legislative regime. It is unclear what, if anything, will result from this concern being raised. However, we understand the MEP was seeking a letter to be written to the Council and the Commission to set out this concern.