EU MDR/IVDR Regulatory News
Latest regulatory updates, standard revisions, and guidance publications in the medical device compliance space.
MDCG 2020-16 Rev.5: Updated IVDR Classification Rules Guidance (September 2026)
2026-09-09 | EU MDR/IVDR | Regulation Update | !! MEDIUM
The European Commission has published revision 5 of MDCG 2020-16, updating guidance on classification rules for in vitro diagnostic medical devices under Regulation (EU) 2017/746 (IVDR). This revision affects IVD manufacturers, notified bodies, and other economic operators who must apply the IVDR classification rules. Stakeholders should review the updated guidance, reassess the risk class of their IVD products, and adjust technical documentation and conformity assessment procedures where necessary.
Tags: ivdr, classification_rules, mdcg_guidance, in_vitro_diagnostics, regulatory_affairs
View Source (European Commission)
New MDCG Position Paper Clarifies UDI Assignment Responsibilities Between Manufacturers and Distributors
2026-07-22 | EU MDR/IVDR | Regulation Update | !! MEDIUM
The European Commission has released a new MDCG position paper on assigning Unique Device Identification (UDI) between manufacturers and distributors under the EU Medical Device Regulations. It clarifies which party is responsible for UDI placement when devices are relabeled, repackaged, or sold under a distributor’s own name, covering manufacturers, importers, and distributors. Affected stakeholders should review the guidance to align their UDI assignment processes with the clarified obligations, especially for private labelling and parallel trade scenarios. Timely adoption is essential to maintain compliance with MDR/IVDR traceability requirements.
Tags: udi, mdcg, guidance, manufacturers, distributors, traceability
View Source (European Commission)
EC Publishes Dashboard v3.5 for Monitoring Medical Device Availability on the EU Market
2026-07-14 | EU MDR/IVDR | Regulation Update | !! MEDIUM
The European Commission has released version 3.5 of the dashboard supporting its study on the availability of medical devices in the EU market. This update provides enhanced data visualization for stakeholders, including manufacturers, notified bodies, and competent authorities, to monitor device supply trends and potential shortages. The dashboard aids in assessing the impact of the MDR/IVDR transition on market access. Affected parties should consult the new version for current market intelligence and compliance planning.
Tags: medical_device_availability, dashboard_update, market_surveillance, eu_mdr
View Source (European Commission)
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)