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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 – 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.

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.

EU - Overview of language requirements published

The EU Commission published an overview of the language requirements for MDR and IVDR in accordance with the respective national law in the member states. The lists are not binding and do contain some empty cells and unconfirmed information but provide a good overview.