News

MDCG settles the UDI dispute: who is actually allowed to assign a code to a distributor?

In July 2026, the Medical Device Coordination Group (MDCG) published Position Paper MDCG 2026-5, resolving a growing interpretive dispute over the ass...

Adrianna Pyrzanowska Regulatory Affairs Associate

The European Commission expands the list of “well-established technologies”. Two delegated regulations amend the rules on technical documentation assessment and clinical investigations for class IIb and III devices

On June 29, 2026, the Official Journal of the European Union published two closely related Commission Delegated Regulations: (EU) 2026/1359 and (EU) 2...

Katarzyna Wesołowska Vice President of the Board
Close-up of modern laboratory microscope in a clinical research facility

Who uploads SSCPs to EUDAMED? The Commission amends the rules

In June 2026, the Medical Devices Coordination Group published document MDCG 2026-4, which sets out the rules for submitting the Summary of Safety and...

Adrianna Pyrzanowska Regulatory Affairs Associate
Long aisle between tall empty blue industrial warehouse shelves, representing medical device supply chain interruption and shortage risk under MDR Article 10a

The MHRA is moving towards full membership of the MDSAP

At the annual MDSAP Forum in Kyoto, the UK’s MHRA announced that it is taking steps towards achieving full membership of the Medical Device Single Aud...

Emilia Geszczyńska Project Manager

New harmonised standards under the MDR. The European Commission updates the list of standards by Decision 2026/1231.

On 11 June 2026, the European Commission published Implementing Decision (EU) 2026/1231, amending the existing list of harmonised standards drawn up f...

Katarzyna Wesołowska Vice President of the Board

ICH E6(R3) Annex 2 adopted. New GCP guidelines for decentralised, pragmatic and real-world data (RWD)-based trials

On 3 June 2026, the ICH Assembly formally adopted, at Step 4 of the ICH process, Annex 2 to the E6(R3) guideline on Good Clinical Practice (GCP). Whil...

Olga Zielińska Lawyer & IODO
EU flag with a judge's gavel, stethoscope and CE conformity assessment certificates on a contract — illustrating harmonised EU rules for notified bodies under MDR and IVDR.

No more unpredictable deadlines and costs in the EU. Implementing Regulation 2026/977 harmonises the rules for conformity assessment under the MDR and IVDR

Implementing Regulation (EU) 2026/977 introduces binding maximum time limits, transparent cost estimates and recertification rules for notified bodies...

Katarzyna Wesołowska Vice President of the Board
Female scientist in a testing laboratory examining medical device samples under a microscope, with a biocompatibility test results screen showing ISO 10993-5, 10993-10 and 10993-12 — illustrating biological evaluation of medical devices.

The FDA recognises the new edition of ISO 10993-1 – what changes does the sixth edition of the biocompatibility standard bring?

The FDA has added the sixth edition of ISO 10993-1 to its recognised consensus standards list, with partial recognition and a transition period until...

Katarzyna Romaniszyn Head of Regulatory and Quality Management Department
Regulatory affairs specialist reviewing a medical device compliance dashboard on a laptop, showing EU MDR compliance scores, UDI device records and certification status — illustrating mandatory EUDAMED registration for manufacturers.

EUDAMED is mandatory from today. What should medical device manufacturers do?

From 28 May 2028 all four EUDAMED modules are mandatory for economic operators. Failure to register can lead to CE marking challenges and market suspe...

Adrianna Pyrzanowska Regulatory Affairs Associate