in force 2025-01-10
02017R0745-20240709 → 02017R0745-20250110
Amended by Regulation (EU) 2024/1860 32024R1860 · Regulation (EU) 2024/568 32024R0568
Regulation (EU) 2024/1860 of the European Parliament and of the Council of 13 June 2024 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices (Text with EEA relevance)
in force 2025-01-01, 2025-01-10 · detected 2026-08-12
2 provisions touched — 2 substantive, 0 date-only, 0 disputed · every change carries an explanation that passed its citation check
INSERTED +1,680 −0 Art. 10a Obligations in case of interruption or discontinuation of supply of certain devices§
applies from: unknown (an inserted provision states its own application date only in prose)
A new Article 10a is added, requiring a manufacturer that anticipates an interruption or discontinuation of supply of a device, other than a custom-made device, reasonably foreseeable to cause serious harm or a risk of serious harm to patients or public health in one or more Member States, to inform the relevant competent authority and the economic operators, health institutions and healthcare professionals it directly supplies, and to state the reasons for the interruption or discontinuation, generally at least six months in advance.
The article further provides that the competent authority receiving this information must, without undue delay, notify the competent authorities of other Member States and the Commission, and that economic operators who receive such information must, without undue delay, pass it on to other economic operators, health institutions and healthcare professionals they directly supply.
Cited: Art. 10a, v2
text before / after
inserted text (02017R0745-20250110)
Article 10a Obligations in case of interruption or discontinuation of supply of certain devices 1. Where a manufacturer anticipates an interruption or a discontinuation of the supply of a device, other than a custom-made device, and where it is reasonably foreseeable that such interruption or discontinuation could result in serious harm or a risk of serious harm to patients or public health in one or more Member States, the manufacturer shall inform the competent authority of the Member State where it or its authorised representative is established, as well as the economic operators, health institutions and healthcare professionals to whom it directly supplies the device, of the anticipated interruption or discontinuation. The information referred to in the first subparagraph shall, other than in exceptional circumstances, be provided at least 6 months before the anticipated interruption or discontinuation. The manufacturer shall specify the reasons for the interruption or discontinuation in the information provided to the competent authority. 2. The competent authority that has received the information referred to in paragraph 1 shall, without undue delay, inform the competent authorities of the other Member States and the Commission of the anticipated interruption or discontinuation. 3. The economic operators who have received the information from the manufacturer in accordance with paragraph 1 or from another economic operator in the supply chain shall, without undue delay, inform any other economic operators, health institutions and healthcare professionals to whom they directly supply the device, of the anticipated interruption or discontinuation.
MODIFIED +559 −43 Art. 106 Provision of scientific, technical and clinical opinions and advice§
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: 2022-01-25
Paragraph 14 changes the phrase describing who the fees are payable to, from fees payable to the Commission to fees established under the procedure in paragraph 13, and rewords the cross-reference to Annex IX, Section 5.1, point (c).
Two new paragraphs are added specifying that fees related to advice from expert panels are payable to EMA under Article 30, point (f), of Regulation (EU) 2022/123, and that fees related to advice from expert laboratories are payable to the Commission.
Cited: Art. 106, v1 · Art. 106, v2
text before / after
02017R0745-20240709 → 02017R0745-20250110
Article 106
Provision of scientific, technical and clinical opinions and advice
1. The Commission shall, by means of implementing acts and in consultation with the MDCG, make provision for expert panels to be designated for the assessment of the clinical evaluation in … 1,035 unchanged words … protection of health and safety, support of innovation and cost-effectiveness and the necessity to achieve active participation in the expert panels. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).
14. The fees payable to the Commission established in accordance with the procedure under paragraph 13 of this Article shall be set in a transparent manner and on the basis of the costs for the services provided. The fees payable shall be reduced in the case of a clinical evaluation consultation procedure initiated in accordance with Section 5.1, point (c) of Section 5.1 (c), of Annex IX involving a manufacturer who is a micro, small or medium-sized enterprise within the meaning of Recommendation 2003/361/EC.
The fees related to the advice provided by expert panels are payable to EMA pursuant to Article 30, point (f), of Regulation (EU) 2022/123 of the European Parliament and of the CouncilRegulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (OJ L 20, 31.1.2022, p. 1)..
The fees related to the advice provided by expert laboratories are payable to the Commission.
15. The Commission is empowered to adopt delegated acts in accordance with Article 115 to amend the tasks of expert panels and expert laboratories referred to in paragraph 10 of this Article.
The full entry, with the citation mapping v1 = 02017R0745-20240709, v2 = 02017R0745-20250110, is committed at eu/32017R0745/CHANGELOG.md.