Medical Device User Fee Rates for Fiscal Year 2027
FDA announces medical device user fee rates and payment procedures for FY 2027 (October 1, 2026 – September 30, 2027) under MDUFA V.
US Federal Register - FDA Notices · United States
Category
General Regulatory
Not every regulatory development fits a single product category. This covers the cross-cutting material: enforcement actions, general guidance, institutional and legislative change, and horizontal rules that touch pharmaceuticals, devices, digital health, and data at the same time.
Regulation
Category
Type · Breadth
Date
Guidance: MHRA Innovation Accelerator
The Innovation Accelerator provides innovators and developers of innovative products access to MHRA scientific expertise, regulatory guidance and an enhanced advice and signposting service.
UK MHRA · UKEU Products Liability Directive (EU) 2024/2853 – National Transposition
Directive clarifies 'product' definition to include digital manufacturing files and software, modernizing liability framework for AI-enabled devices and SaMD.
EUR-Lex Official Journal · EU-wideMHRA Innovation Office: guidance and support
We can provide access to world-class regulatory knowledge, expertise and experience from within the MHRA.
UK MHRA · UKForms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry
FDA announces draft guidance answering common questions on Forms 3542a and 3542 for applicants submitting to the Agency.
US Federal Register - FDA Guidance Notices · United StatesCommission Implementing Decision (EU) 2026/901 on European standards for products under Regulation (EU) 2023/988, repealing Decision (EU) 2019/1698
Implementing decision establishing European standards for products under the medical devices framework, repealing the prior 2019 decision.
EUR-Lex Official Journal · EU-wideEuroHPC Regulation amended to strengthen Europe's AI and quantum capabilities
The EuroHPC Regulation has been amended to enhance Europe's artificial intelligence and quantum computing infrastructure capabilities.
EC AI Act & Regulation · EU-wideDigital Europe Programme amended to accelerate the Commission's digital ambitions
The Digital Europe Programme has been amended to accelerate the Commission's digital ambitions.
EC AI Act & Regulation · EU-wideEU HTA Regulation Implementation: Factsheets and guidance materials
Factsheets on joint clinical assessment and scientific consultation procedures under the EU HTA Regulation, plus implementation guidance and analysis of regional cooperation structures.
EU HTA Regulation Implementation · EU-wideAI Act complaints tool
The AI Act Complaint Tool allows individuals and organisations to submit complaints to the AI
EU AI Act Implementation · EU-wideBioVigilance web application launched for reporting adverse events related to substances of human origin
FAMHP launches BioVigilance, an online application for reporting serious adverse events and reactions related to reproductive and non-reproductive substances of human origin intended for human application.
FAMHP (Belgian Medicine Agency) · BelgiumANS-Formation: new interactive content on e-health uses added to platform
ANS-Formation platform launches new immersive module 'The e-health city' offering interactive discovery of digital health applications and use cases.
ANS - French Digital Health Agency · FranceAEPD reopens registration for public network of research groups and projects on privacy and emerging technologies
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AEPD (Spanish Data Protection Agency) · SpainLorenzo Cotino: "AI governance requires the involvement of all institutions and a special commitment from companies"
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AEPD (Spanish Data Protection Agency) · SpainAI Act Whistleblower Tool
The AI Office launches a secure whistleblower reporting tool for individuals to report potential AI Act violations affecting fundamental rights, health, or public trust.
EC AI Act & Regulation · EU-wideEDPB calls for legal basis for cross-regulatory information sharing
EDPB calls for a clear legal basis enabling information sharing among regulators with different competences to support consistent GDPR application.
EDPB (European Data Protection Board) · EU-wideProfessor Joann Rhodes: The Rules Need to Bend – Why Flexible Policies and Real Partnership are the Keys to unlocking Life Sciences Potential
Innovation doesn’t wait for the rules to catch up. The question is whether we can build a system agile and flexible enough to keep pace.
UK MHRA · UKMedicines and Medical Devices Act 2021: 5 year report
Report assessing how UK human and veterinary medicines and medical devices legislation has operated from 2021 to 2026.
UK DHSC · UKHealth Technology Assessment – 2026 Work Programme adopted
News announcement 2 December 2025 Health Technology Assessment – 2026 Work Programme adopted Health Technology Assessment – 2026 Work Programme adopted 1 min read
EC Public Health · EU-wideEU HTA Regulation: implementation rolling plan
TheRegulation (EU) 2021/2282 on health technology assessment(HTAR) entered into force on 11 January 2022 and applies from 12 January 2025.
EU HTA Regulation Implementation · EU-wide
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