Health-tech regulation, tracked.

Health Data, Technology, and Interoperability: ONC Deregulatory Actions To Unleash Prosperity

Final rule removes and revises health IT certification criteria and regulatory provisions to reduce burden and support innovation.

New revision of the MDCG Position Paper on the management of SSCP in EUDAMED after mandatory use

MDCG revised its position paper on managing serious incidents and recalls in EUDAMED following mandatory system implementation.

Register medical devices to place on the market

MHRA guidance on the registration process and requirements for medical devices in Great Britain and Northern Ireland.

Guidance: What the National Commission's recommendations mean for you

Guidance on implementing National Commission recommendations to improve safety, clarity and fairness in healthcare AI across the UK.

Government Response to the National Commission's Recommendations on the Regulation of AI in Healthcare

Government response clarifying how it intends to implement the independent National Commission's recommendations on AI regulation in healthcare.

Study: The Use of Data in Public Health - Understanding the Potential for Artificial Intelligence in Medicine

Study examines AI technologies in healthcare, EU legal frameworks for data reuse in medical AI development, and presents policy recommendations to address implementation challenges.

Proposal for regulation of a national digital infrastructure in the health data area

Swedish eHealth Agency submits consultation response on government proposal for national health data infrastructure regulation.

Unified rules for health data exchange between hospitals and medical practices

gematik opens public consultation on standardised rules for interoperable health data exchange across healthcare software systems.

Government confirms indefinite recognition of CE marked medical devices

UK extends indefinite recognition of CE-marked medical devices and IVDs already approved for the EU market.

European Health Data Space: contribute to European work

European Commission launches Forum and Stakeholder Community to support implementation of the European Health Data Space (EHDS), inviting patients, healthcare professionals, companies and researchers to participate.

Commission Implementing Regulation (EU) 2026/2099 on interoperable cross-border identification and authentication for electronic health data exchange

Establishes interoperable cross-border identification and authentication mechanism for natural persons, health professionals and healthcare providers for cross-border personal electronic health data exchange.

Enhanced support for connection to the national digital infrastructure

The connection portal for Sweden's national digital health infrastructure now provides improved support for organisations preparing to connect.

Commission Implementing Regulation (EU) 2026/2083 on MyHealth@EU

National Commission into the Regulation of AI in Healthcare: Recommendations for a future regulatory framework

Commission recommends a future regulatory framework for AI in healthcare, advising government on governance and oversight mechanisms.

Fact check: Are information and data in the ePA really secure and cannot fall into the hands of unauthorised persons?

gematik explains ePA data protection and security architecture, confirming that only patients and authorised medical personnel can access records through Germany's secure health network.

Bill: Reprocessing of single-use medical devices permitted from 1 January 2027

Finland proposes legislation permitting reprocessing of single-use medical devices from 1 January 2027.

Medical device instructions for use must be accessible and understandable to the user

Patient reported outcomes (PROs) resources for digital mental health technologies

Resources to help developers use patient-reported outcomes in digital mental health technologies for evidence generation, monitoring and user safety.

Guidance: Good machine learning practice for medical device development

Ten guiding principles for developing machine learning-based medical devices.

Common terminology for easier development of digital health services

E-hälsomyndigheten publishes a terminology catalogue with standardised terms and quality-assured definitions for health, care and social services.

Updated criteria strengthen national common specifications

E-hälsomyndigheten updated assessment criteria for e-health specifications eligible for national common specification status.

Clinical investigations for medical devices

Guidance on how to notify the MHRA of intention to carry out a clinical investigation for medical devices.

CLIA: Virtual Access, Gynecologic Cytology Proficiency Testing, Personnel Qualifications, and Other Changes — Proposed Rule

Proposed amendments to CLIA regulations to permit virtual access for laboratory testing data, digital images for cytology proficiency testing, and updated personnel and reporting requirements.

AI-enabled biological design: trends, opportunities and regulatory choices for the European Union

Briefing on AI use in protein, peptide and nucleic acid design across biopharmaceutical research, industrial biotechnology and vaccine development, with regulatory implications for the EU.

Commission Implementing Regulation (EU) 2026/2098 on minimum metadata elements for health data holder dataset descriptions under the European Health Data Space

Establishes minimum metadata elements and characteristics that health data holders must provide for dataset descriptions enabling secondary use of electronic health data under EHDS.

MDCG 2020-16 rev.5 - Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746

Revised guidance on IVDR classification rules for in vitro diagnostic devices published.

Essential Drug Delivery Performance Characteristics for Devices Intended To Deliver Drugs and Biological Products; Revised Draft Guidance for Industry

FDA revises draft guidance on drug delivery device performance characteristics, data organization and regulatory review standards for combination products.

Regulatory Considerations for Prescription Drug Use-Related Software; Guidance for Industry

FDA guidance on regulatory application of drug labeling authorities to software outputs disseminated by or on behalf of drug sponsors for use with prescription drugs.

AI Act for Medical Devices

High-risk AI systems in medical devices must meet AI Act requirements on risk management, data governance, documentation, logging, transparency and oversight, with penalties up to €15M or 3% of global turnover.

Health Bill: medical device licensing regime - impact assessment

Impact assessment of proposed changes to the UK medical device licensing regime under the Health Bill.