MDN News Collection

Regulatory news items selected in MDN – Medical Device News, organized by date, source, thematic area, and scope. Use the search function to quickly find the updates that interest you.

Date	News title	Source	Thematic area	Scope	MDN issue
17/06/2026	European Commission updates harmonised standards references under the MDR and IVDR	European Commission / Official Journal of the European Union	Harmonised standards	MDR / IVDR	MDN #007 - News 1
18/06/2026	MDCG publishes transitional arrangements for the management of SS(C)P in EUDAMED	Medical Device Coordination Group	EUDAMED	MDR / IVDR	MDN #007 - News 2
17/06/2026	MDCG provides guidance on the transition to the “EU REP” symbol	Medical Device Coordination Group	Labelling / symbols	MDR / IVDR	MDN #007 - News 3
17/06/2026	FDA classifies machine learning-based imaging software with a PCCP into class II	FDA / Federal Register	Software / AI	FDA	MDN #007 - News 4
17/06/2026	FDA classifies ingestible gastrointestinal blood detection capsules into class II	FDA / Federal Register	Gastrointestinal diagnostics	FDA	MDN #007 - News 5
10/06/2026	Team-NB publishes IVDR application and surveillance transfer agreement template	Team-NB	IVDR transition	IVDR	MDN #006 - News 1
11/06/2026	FDA classifies two IVD device types into class II with special controls	FDA / Federal Register	IVD classification	FDA / IVD	MDN #006 - News 2
08/06/2026	FDA issues Early Alert on Hamilton Medical breathing circuit sets	FDA / CDRH	Safety communications	FDA / Medical devices	MDN #006 - News 3
11/06/2026	FDA issues Early Alert on Baxter Volara System patient circuits	FDA / CDRH	Safety communications	FDA / Medical devices	MDN #006 - News 5
11/06/2026	FDA identifies Abiomed Automated Impella Controllers correction as the most serious type of recall	FDA / CDRH	Recalls / corrections	FDA / Medical devices	MDN #006 - News 4
04/06/2026	Team-NB publishes Version 2 of its MDR certification process consensus document	Team-NB	MDR certification	MDR	MDN #005 - News 1
05/06/2026	FDA announces updated guidance on premarket notification exemptions for certain unclassified devices	FDA / CDRH / Federal Register	510(k) / Premarket notification	FDA	MDN #005 - News 2
01/06/2026	ISO publishes the June 2026 ISO Update	ISO	Technical standardisation	MDR / IVDR / IVD / Medical devices	MDN #005 - News 3
02/06/2026	FDA issues Early Alert on Abiomed catheter introducer kits	FDA / CDRH	Safety communications	FDA / Medical devices	MDN #005 - News 4
05/06/2026	FDA issues Early Alert on GE HealthCare infant resuscitation systems	FDA / CDRH	Safety communications	FDA / Medical devices	MDN #005 - News 5
28/05/2026	EUDAMED: first four modules become mandatory from 28 May 2026	European Commission / DG SANTE	EUDAMED	MDR / IVDR	MDN #004 - News 1
26/05/2026	Team-NB publishes legal expert opinion on MDR Article 50	Team-NB	MDR / Notified bodies	MDR	MDN #004 - News 2
27/05/2026	FDA issues Early Alert on certain ICU Medical IV tubing sets	FDA / CDRH	Safety communications	FDA / Medical devices	MDN #004 - News 3
29/05/2026	FDA updates medical device safety notices and recall listings	FDA / Medical Device Safety	Recalls / safety alerts	FDA / Medical devices	MDN #004 - News 4
25/05/2026	FDA recognizes ISO 10993-1:2025	FDA / Recognized Consensus Standards Database	Recognized standards / biocompatibility	FDA / Medical devices	MDN #004 - News 5
05/05/2026	European Commission highlights Implementing Regulation (EU) 2026/977 on notified body conformity assessment activities	European Commission / DG SANTE	Notified bodies / conformity assessment	MDR / IVDR	MDN #003 - News 1
22/05/2026	Italy issues updated operational communication on MIR 7.3.1 submissions through Dispovigilance	Italian Ministry of Health / DGDMF	Vigilance / incident reporting	Italy / MDR / IVDR	MDN #003 - News 2
21/05/2026	FDA Early Alert: Abiomed Automated Impella Controllers affected by software restart issue	FDA / CDRH	Safety communications	FDA / Medical devices	MDN #003 - News 3
21/05/2026	FDA recall: React Health VOCSN V+Pro ventilators	FDA / CDRH	Recalls / respiratory devices	FDA / Medical devices	MDN #003 - News 4
20/05/2026	FDA Class I recall update: Bolton Medical Relay Pro thoracic stent graft system	FDA / CDRH	Recalls / cardiovascular devices	FDA / Medical devices	MDN #003 - News 5
06/05/2026	FDA Early Alert: Draeger Atlan A350 / A350 XL anesthesia workstations	FDA / CDRH	Safety communications	FDA / Medical devices	MDN #002 - News 1
13/03/2026	FDA Class I recall: AVID Medical convenience kits containing Namic RA syringes	FDA / CDRH	Recalls / angiographic devices	FDA / Medical devices	MDN #002 - News 2
15/05/2026	Italy: Ministry of Health recall notice for NAMIC ANGIOGRAPHIC CONTROL SYRINGE	Italian Ministry of Health	Vigilance / recalls	Italy / Medical devices	MDN #002 - News 3
12/05/2026	Italy: Ministry of Health safety information notice for SCHILLER FRED EASY G2 DA	Italian Ministry of Health	Vigilance / safety notices	Italy / Medical devices	MDN #002 - News 4
12/05/2026	Italy: Ministry of Health recall notice for ADHESE 2 VIVAPEN kit and cannulas	Italian Ministry of Health	Vigilance / recalls	Italy / Medical devices	MDN #002 - News 5
05/05/2026	Commission Implementing Regulation (EU) 2026/977 published	European Commission / EUR-Lex	Notified bodies / conformity assessment	MDR / IVDR	MDN #001 - News 1
07/05/2026	EU updates MIR 7.3.1 PDF and clarifies accepted versions from 1 May 2026	European Commission / DG SANTE	Vigilance / incident reporting	MDR / IVDR	MDN #001 - News 2
07/05/2026	FDA updates safety communication on Boston Scientific ACCOLADE pacemakers	FDA / CDRH	Safety communications	FDA / Medical devices	MDN #001 - News 3
06/05/2026	FDA publishes final guidance on patient-matched guides for orthopedic implants	FDA / CDRH	Orthopedic devices / premarket submissions	FDA	MDN #001 - News 4
05/05/2026	FDA updates Class I recall communication for Intuitive Surgical SureForm 30 Gray Reloads	FDA / CDRH	Recalls / surgical devices	FDA / Medical devices	MDN #001 - News 5