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EU - Update of the SCHEER guidelines for risk-benefit-assessment of phthalates

The Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) has published an update of the guidelines on the benefit-risk assessment of phthalates with carcinogenic, mutagenic, reproduction toxic or endocrine disruptive properties. The guideline can also be used for other substances with comparable properties, the presence of which above a certain threshold requires a justification according to MDR Annex I.

EU - New and updated MDCG guidance documents

In May the MDCG published several new guidance documents. MDCG 2024-6 to -9 containt templates for the (re-)assessemnt of Notified Bodies by the authorities. In addition MDCG 2022-4 dealing with appropriate surveillance of legacy devices was updated and is now available in revision 2.

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.