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EU - Updates to the list of harmonised standards for MDR and IVDR

On 2024-10-08 the EU published amendments with harmonised standards for Regulation (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR) in the official journal (implementing decision (EU) 2024/2631 and (EU) 2024/2625).. The number of harmonised standards increases by one for the MDR (to now 25) and by two for the IVDR (to now 15).

Consolidated summary lists of the harmonised standards are published here for the MDR and hier for the IVDR.

EU - New MDCG Guidance Documents

The MDCG has published two new guidance documents: MDCG 2024-11 covers the qualification of in vitro diagnostic medical devices. MDCG 2024-12 provides information for Notified Bodies with respect to corrective and preventive action during the joint assessment by authorities. Back in semptember MDCG 2021-4 Rev.1 was published, an update on the application of transitional provisions for certification of class D IVDs .

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 - 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 - 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.