EU MDR/IVDR Regulatory News
Latest regulatory updates, standard revisions, and guidance publications in the medical device compliance space.
EC Publishes Delegated Acts on Well-Established Technologies Under EU MDR
2026-06-30 | EU MDR/IVDR | Regulation Update | !!! HIGH
The European Commission has published new delegated acts concerning well-established technologies (WET) under the Medical Devices Regulation (MDR). This update affects manufacturers of specific Class IIb implantable and Class III devices, such as sutures, staples, and bone screws, by clarifying exemptions for clinical investigations. Affected manufacturers must review the updated acts upon entry into force to verify their eligibility for WET exemptions and adjust their clinical evaluation strategies accordingly.
Tags: eu_mdr, delegated_act, well_established_technologies, clinical_evaluation
View Source (European Commission)
Commission Implementing Decision (EU) 2026/1231 -- Updated Harmonised Standards for MDR
2026-06-17 | EU MDR/IVDR | Regulation Update | !!! HIGH
Published 17 June 2026 (effective 11 June 2026), this decision amends Decision 2021/1182 and updates harmonised standard references across nine medical device categories: biological evaluation (EN ISO 10993-12:2021/A1:2025), labelling/symbols (EN ISO 15223-1:2021/A1:2025), electromedical equipment, transfusion equipment, ophthalmic optics, non-active surgical implants, washer-disinfectors, prostheses, and sharps injury protection. Manufacturers must review technical documentation, declarations of conformity, and test reports against updated standard references.
Tags: harmonised_standards, biological_evaluation, labelling, conformity
MDCG 2026-4: Management of SS(C)P in EUDAMED After Mandatory Use
2026-06-02 | EU MDR/IVDR | New Guidance | !!! HIGH
Published June 2026, MDCG 2026-4 transfers SSCP/SSP upload responsibility from Notified Bodies to manufacturers in EUDAMED. Key dates: from 28 May 2026 Notified Bodies continue uploading during transition; from October 2026 manufacturers take over direct upload; deadline 27 February 2027 for devices already on market. Manufacturers must upload master SS(C)P and translations, ensuring the uploaded version matches the one validated during certification.
Tags: eudamed, sscp, notified_body, manufacturer_obligation
View Source (European Commission)