News

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
Clinician using an AI diagnostic assistant on a tablet to analyse a lung CT scan, with neural network visualisation and ROC curve on a secondary monitor — illustrating high-risk AI medical software under the EU AI Act.

The European Commission is consulting on draft guidelines for the classification of high-risk AI systems. What does this mean for medical device manufacturers?

Draft EU guidelines confirm that every MDR/IVDR-regulated medical device with an AI component is automatically classified as high-risk under the AI Ac...

Izabela Chodara President of the Board
Healthcare professional in scrubs interacting with a holographic Gantt chart and digital clinical trial dashboard on a tablet, representing real-time clinical trial monitoring and data flow

FDA moves towards real-time clinical trials

FDA launches proof-of-concept real-time trials with AstraZeneca and Amgen plus a broader summer pilot — streaming key endpoints to regulators reshapes...

Ilona Korczak-Cegielska Director of Clinical and Regulatory Operations
Tablet displaying a holographic human anatomy and DNA helix surrounded by medical icons, stethoscope, syringe and patient history form, symbolising breakthrough medical device innovation

EMA Pilot for Breakthrough Devices

EMA launches a pilot in Q2 2026 to support breakthrough medical devices and IVDs — earlier dialogue with regulators, closer EMA/MDCG cooperation, high...

Katarzyna Romaniszyn Head of Regulatory and Quality Management Department
Businessman in suit adjusting a glowing pink-to-blue vertical slider between HIGH and LOW marked RISK, illustrating medical device risk classification under MDR

MDCG Updates on borderline and classification. Raising the bar for Medical Device Manufacturers.

Updated Borderline Manual (Version 5) and MDCG 2021-24 Rev.1 raise the bar for classification of medical devices — mode of action, software and substa...

Katarzyna Wesołowska Vice President of the Board
Long aisle between tall empty blue industrial warehouse shelves, representing medical device supply chain interruption and shortage risk under MDR Article 10a

MDR Article 10a – notification duties when supply is interrupted

From 10 January 2025 manufacturers must notify authorities at least six months before a supply interruption or discontinuation that could harm patient...

Adrianna Pyrzanowska Regulatory Affairs Associate
Professional examining regulatory compliance documents through a magnifying glass with digital document icons in the background

ISO 14155:2026 — A Revised Framework for Clinical Investigations under MDR: Practical Perspectives from Pure Clinical

ISO 14155:2026 brings a revised GCP framework for clinical investigations under MDR — covering PMCF, SaMD, and clarified stakeholder roles. A practica...

Katarzyna Wesołowska Vice President of the Board