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EU - European parliament approves changes to MDR and IVDR
In its last session before the pending EU elections, the EU parliament approved the regulation to change MDR and IVDR with respect to gradual roll-out of Eudamed, information obligation in case of interruption of supply and transitional provisions for IVDs on April 25th. Before publication in the official EU journal and entry into force, the Council of the European Union must approve the changes.
EU - Updated list of planned MGCG guidance documents
The EU has published an updated list of MDCG guidance documents currently under development on the MDCG webpages. The list includes more than 40 entries concerning planned new guidances and updates to existing ones that are planned to be published in 2024.
EU – Update of the lists of harmonised standards for MDR and IVDR
The EU published two implementing decisions expanding the list of harmonised standards for MDR and IVDR. The decisions add 8 standards for MDR (25 in total) and 3 for IVDR (13 in total). The newly added standards address aspects of biological evaluation, processing (both for MDR), radiation sterilization and sterile packaging (MDR and IVDR). Consolidated summary lists of harmonised standards can be found on the respective EU websites for MDR and IVDR.
EU – New MDCG guidance document on content of the clinical investigation plan for medical devices
The MDCG published a new guidance document (MDCG 2024-3) that details the requirements for the content of the clinical investigation plan that must be included in the application for clinical investigations for medical devices. Aside from a description of required contents, the document gives a template for the clinical investigation study plan synopsis in Annex A that is available as Word document.
EU –Judgement of the EU court of justice with respect to access to harmonised standards
In a judgement from March 5 (C-588/21 P) the European Court of Justice confirmed its position that harmonised standards form a part of EU law. Consequently, the court ruled that there is an overriding public interest justifying the disclosure of harmonised standards in accordance with applicable EU rules for transparency. The Court did not explicitly address questions of copyright protection. It remains open how far reaching the right of access is and how access should be realised.
USA - FDA issues “final rule“ to amend 21 CFR 820
The FDA has issued a „final rule“ that implements the annouced amendment of 21 CFR 820 (and 21 CFR 4 for combination products) to harmonize the requirements for quality management systems for medical devices with ISO 13485:2016. Formal publication date is 2024-02-02, the rule will be effective 2026-02-02.
EU - MDCG publishes templates and first cases of Device Specific Vigilance Guidances
MDCG 2024-1 contains a template for Device Specific Vigilance Guidances (DSVG). Concrete guidande documents will bear an additional ongoing number (MDCG 2024-1-X). The first four DSVGs address (comparable to their MEDDEV predecessors) cardiac ablation, coronary stents, cardiac implantable electronic devices (CIEDs) and breast implants.
The EU-commission on 23.01.2024 published several documents detailing proposals with the aim to improve transition to MDR and IVDR and ensure availability of devices. These encompass a press release, a Q&A page, a Factsheet and a proposal for a new Regulation to change MDR and IVDR.
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