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Rechtspraak
Hoge Raad
Conclusie PG HR 30 juni 2030, ECLI:NL:PHR:2023:644 (Eiseres tegen VGZ)
Unierecht. Gezondheidsrecht. Vergoeding van heupoperatie ondergaan in België. Moet vergoeding van Nederlandse zorgverzekeraar gelijk zijn aan die voor een Nederlandse gecontracteerde of voor een niet-gecontracteerde zorgaanbieder? Richtlijn 2011/24/EG (Patiëntenrichtlijn), Verordening 2004/883 (Coördinatieverordening) en art. 56 VWEU (vrij verkeer van diensten). Horizontale werking?
Europese Unie
Notified Bodies Survey on certifications and applications (MDR/IVDR) (Survey results with data status 31 March 2023) - Updated document
European Commission, 25 July 2023
Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices
The amendment of the MDR and of the IVDR through Regulation (EU) 2023/607 aims to ensure a high level of public health protection, including patient safety and an avoidance of shortages of medical devices needed for the smooth functioning of healthcare services, without lowering current quality or safety requirements. For that purpose, manufacturers and notified bodies are given sufficiently more time to carry out, in accordance with the MDR, the conformity assessment of devices covered by a certificate or a declaration of conformity issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC. Moreover, the deletion of the ‘sell off’ date in the MDR and the IVDR aims to prevent unnecessary disposal of safe devices.
The answers to the questions set out below have been developed taking into account the objectives pursued by the amendment with a view to making best use of the additional time provided by the extension of the MDR transitional period.
European Commission, 18 July 2023
European Commission approves updated regulation to ease contact lens UDI requirements
The European Commission has agreed to amend the EU Medical Device Regulation (MDR) to ease the Unique Device Identifier (UDI) requirements for certain products, starting with contact lenses. Once adopted, the regulation will allow contact lens manufacturers to assign a Master UDI-DI to certain products instead of a UDI-DI.
On 10 July, the Commission adopted a Delegated Regulation that would allow standard contact lenses and made to order contact lenses with the same design parameters to be grouped under one Master UDI device identifier (UDI-DI). The change is meant to help lower administrative burdens for manufacturers that are otherwise available in other jurisdictions.
In a memorandum explaining its decision, the Commission said that after years of experience implementing its UDI regulations, regulators realized that the current UDI requirements may be unnecessarily burdensome for certain products. Creating the Master UDI-DI system is meant to reduce burdens in those cases.
RAPS, 12 July 2023
Harmonised standards
Harmonised standards under the medical devices Regulations are developed by CEN and CENELEC as European standardisation organisations, on the basis of a Standardisation Request issued by the Commission according to Regulation (EU) No 1025/2012. Once their references are published by the Commission in the Official Journal of the European Union, the voluntary use of those standards confer presumption of conformity with the requirements of the Regulations they aim to cover. The publications in the OJEU of references of harmonised standards under the medical devices regulations are available:
For Regulation (EU) 2017/745 on medical devices:
- Commission Implementing Decision (EU) 2023/1410 of 4 July 2023
- Commission Implementing Decision (EU) 2022/757 of 11 May 2022
- Commission Implementing Decision (EU) 2022/6 of 4 January 2022
- Commission Implementing Decision (EU) 2021/1182 of 16 July 2021
For Regulation (EU) 2017/746 on in vitro diagnostic medical devices:
- Commission Implementing Decision (EU) 2023/1411 of 4 July 2023
- Commission Implementing Decision (EU) 2022/729 of 11 May 2022
- Commission Implementing Decision (EU) 2022/15 of 6 January 2022
European Commission, 6 July 2023
Overheidsinformatie
GMH
Rapportage GMH Transparantieregister Zorg 2022
Het Transparantieregister Zorg in 2022
Nieuwsbrief GMH, 25 Juli 2023
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