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EU - regulation changing MDR and IVDR published in EU journal
After passing the parliament and councils the regulation to change MDR and IVDR has now been published in the officiel EU journal as Regulation (EU) 2024/1860. The regulation is immediately in force and applicable with the exception of the reporting obligations to manufacturers in case of shortages of certain medical devices that will become applicable on January 10 2025.
EU - Q&A document on changed IVDR transition timelines published
After the publication of Regulation (EU) 2024/1860 in the official journal, the commission has now provided a Q&A document that explains the new timelines and provisions with respect to the changes in the IVDR transition period. Additional Q&A documents for the newly introduced obligation to inform in case of interruption or discontinuation of supply for manufacturers and the gradual roll-out of EUDAMED will follow.
EU - Updates to MDCG guidance documents
The MDCG updated two of its guidance documents:
MDCG 2021-5 provides information on standardisation for medical devices and was updated to revision 1. MDCG 2020-16 explains the classification rules for in-vitro diagnostics and is now available in revision 3.
EU - MDCG Guidance on Clinical Evaluation for Orphan Medical Devices
The MDCG published MDCG 2024-10 that includes guidelines for the clinical evaluation of orphan devices. The guideline defines orphan devices as indicated for diseases or conditions that present in not more than 12.000 individuals per year within the EU. In addition there have to be either insufficient treatment options or an expected improved benefit by the device under evaluation.
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 - Council approves changes to MDR and IVDR
After the EU Parliament now the Council has adopted a regulation changing the MDR and IVDR (press release). The only missing step now is the publication in the Official Journal. The changes introduced include further extending the transition period for certain IVDs, enabling a gradual roll-out of EUDAMED, and requiring manufacturers to flag up potential shortages of critical medical devices and IVDs.
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.