in force 2020-04-24 MODIFIED+576 −15§
Amended by Regulation (EU) 2020/561 32020R0561
applies from: unknown (the text changed beyond its dates, so no date that moved can be read as the application date)
dates added to the text: 2020-04-24, 2021-05-25
Paragraph 1 now adds an alternative derogation, allowing authorisation for the period from 24 April 2020 to 25 May 2021 by way of derogation from provisions of Directive 90/385/EEC or Directive 93/42/EEC, alongside the existing derogation from Article 52, and refers to procedures in "those Articles" rather than "that Article".
Paragraph 2 adds a new sentence stating that a Member State may inform the Commission and other Member States of authorisations granted under Article 9(9) of Directive 90/385/EEC or Article 11(13) of Directive 93/42/EEC before 24 April 2020.
Paragraph 3 adds wording allowing the Commission to extend the validity of an authorisation granted before 24 April 2020 under Article 9(9) of Directive 90/385/EEC or Article 11(13) of Directive 93/42/EEC, in addition to authorisations under paragraph 1.
Cited: Art. 59, v2
text before / after
02017R0745-20170505 → 02017R0745-20200424
Article 59
Derogation from the conformity assessment procedures
1. By way of derogation from Article 52, 52 of this Regulation or, for the period from 24 April 2020 to 25 May 2021, by way of derogation from Article 9(1) and (2) of Directive 90/385/EEC or from Article 11(1) to (6) of Directive 93/42/EEC, any competent authority may authorise, on a duly justified request, the placing on the market or putting into service within the territory of the Member State concerned, of a specific device for which the applicable procedures referred to in that Article those Articles have not been carried out but use of which is in the interest of public health or patient safety or health.
2. The Member State shall inform the Commission and the other Member States of any decision to authorise the placing on the market or putting into service of a device in accordance with paragraph 1 where such authorisation is granted for use other than for a single patient.
The Member State may inform the Commission and the other Member States of any authorisation granted in accordance with Article 9(9) of Directive 90/385/EEC or Article 11(13) of Directive 93/42/EEC before 24 April 2020.
3. Following a notification pursuant to paragraph 2 of this Article, the Commission, in exceptional cases relating to public health or patient safety or health, may, by means of implementing acts, extend for a limited period of time the validity of an authorisation granted by a Member State in accordance with paragraph 1 of this Article or, when granted before 24 April 2020, in accordance with Article 9(9) of Directive 90/385/EEC or Article 11(13) of Directive 93/42/EEC to the territory of the Union and set the conditions under which the device may be placed on the market or put into service. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).
On duly justified imperative grounds of urgency relating to the health and safety of humans, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 114(4).