Clinical investigations for medical devices
Guidance on how to notify the MHRA of intention to carry out a clinical investigation for medical devices.
UK MHRA · UK
Category
Clinical Trials & Research
Clinical trials regulation sets how human research is authorised, conducted, and reported. In the EU, Regulation 536/2014 harmonised assessment through the Clinical Trials Information System, and Good Clinical Practice, ethics committee review, safety reporting, and transparency obligations apply throughout.
Regulation
Category
Type · Breadth
Date
Guidance: Approving clinical investigations
MHRA guidance on the approval process and criteria for clinical investigations of medical devices.
UK MHRA · UKM11 Clinical Electronic Structured Harmonised Protocol (CeSHarP); Guidance for Industry
FDA announces final ICH guidance on harmonized digital clinical trial protocol standards, templates, and technical specifications for international regulatory exchange.
US Federal Register - FDA Guidance Notices · United StatesGuidance: Clinical investigations: investigators' responsibilities
Guidance on investigator obligations and requirements for clinical investigations of medical devices under MHRA regulation.
UK MHRA · UKGeneral Principles on the use of Artificial Intelligence in the preparation of the JCA dossier
EC Public Health publishes general principles governing AI use in preparing Joint Clinical Assessment dossiers.
EC Public Health · EU-wideGuidance: Clinical investigations: compiling a submission
Guidance on how to notify the MHRA of a planned clinical investigation of a medical device.
UK MHRA · UKEstablishment of a Quantitative Medicine Innovation Network: Scope, Feasibility, and Opportunities; Request for Information
FDA CDER requests feedback on developing a cross-sector collaborative platform to advance quantitative medicine approaches in drug development and regulatory science.
US Federal Register - FDA Notices · United StatesSocialstyrelsen Regulations HSLF-FS 2026:31: Amendment to regulations on exemptions from licensing requirement for genetic testing in general health screening
Amendment to Swedish regulations exempting genetic testing from licensing requirements when conducted as part of general health screening programmes.
Socialstyrelsen - Föreskrifter (SE) · SwedenPotency Assessment of Active Immunotherapy Products; Draft Guidance for Industry
FDA announces draft guidance on designing, validating and evaluating potency assays for active immunotherapy products including peptide and protein-based ACTIMPs.
US Federal Register - FDA Guidance Notices · United StatesGuidance: Clinical investigations for electrically powered devices
Guidance on information requirements for notifying the MHRA of clinical investigation plans for electrically powered devices.
UK MHRA · UKGuidance: Clinical investigations: biological safety assessments
Guidance on conducting biological safety evaluation required before undertaking clinical investigations for medical devices.
UK MHRA · UKGuidance: Clinical investigations: statistical considerations
Guidance on statistical data requirements for clinical investigations of medical devices.
UK MHRA · UKGuidance: Clinical trials: Phase 1, 14-Day Pilot Programme
MHRA pilot programme to deliver first-wave regulatory assessment of qualifying Phase 1 applications within 14 calendar days by end of 2026.
UK MHRA · UKEuropean Biotech Act: amendments 2802–2985 to draft report on strengthening Union biotechnology and biomanufacturing sectors
Parliamentary amendments to draft legislation establishing a framework for strengthening EU biotechnology and biomanufacturing, amending food, ATMP, clinical trials, veterinary, and related regulations.
European Parliament - SANT Subcommittee (Public Health) · EU-wideEuropean Biotech Act: amendments 2522–2801 to draft report on strengthening Union biotechnology and biomanufacturing sectors
Parliamentary amendments to draft legislation establishing a framework for strengthening EU biotechnology and biomanufacturing, amending food, ATMP, clinical trials, veterinary, and related regulations.
European Parliament - SANT Subcommittee (Public Health) · EU-wideFinnish translation of Good Clinical Practice (GCP) guidance published
Fimea has published a Finnish-language translation of Good Clinical Practice guidance.
Finland Fimea · FinlandFimea continues to provide CTIS guidance to clinical trial researchers on an as-needed basis
Fimea will continue to offer targeted guidance to clinical trial researchers on CTIS (Clinical Trials Information System) use as needs arise.
Finland Fimea · FinlandFrequently Asked Questions—Developing Potential Cellular and Gene Therapy Products; Final Guidance for Industry
FDA finalizes guidance on development of cellular and gene therapy products, addressing regulatory, manufacturing, pharmacology, clinical and pharmacokinetic questions.
US Federal Register - FDA Guidance Notices · United StatesGuidance: Clinical trials that include an in vitro diagnostic device
Guidance on submitting applications for clinical trials that include an in vitro diagnostic device.
UK MHRA · UKM15 General Principles for Model-Informed Drug Development; ICH Guidance for Industry
FDA finalizes ICH M15 guidance on model-informed drug development planning, evaluation, documentation, and regulatory submission.
US Federal Register - FDA Guidance Notices · United StatesUpdated Questions and Answers on general methodological and procedural issues for joint clinical assessments
Updated guidance on methodology and procedure for joint clinical assessments under the EU HTA Regulation.
EC Public Health · EU-wideACT EU: Support for non-commercial sponsors
ACT EU initiative identifies regulatory and operational bottlenecks for non-commercial clinical trial sponsors and establishes support measures including a helpdesk for CTIS navigation and regulatory guidance.
ACT EU - Accelerating Clinical Trials · EU-wideQuestions and Answers on general methodological and procedural issues for joint clinical assessments
Guidance clarifying methodological and procedural requirements for joint clinical assessments under the EU HTA Regulation.
EC Public Health · EU-wideMaster Protocols for Drug and Biological Product Development; Draft Guidance for Industry
FDA revises draft guidance on design, analysis and regulatory submission of master protocol trials for drug and biological product development.
US Federal Register - FDA Guidance Notices · United StatesClinical trials for medicines: Clinical Trials Regulations transitional arrangements
Guidance on transitional arrangements for the Clinical Trials Regulations.
UK MHRA · UKDemonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products; Revised Draft Guidance for Industry
FDA revises draft guidance on clinical evidence standards for drug effectiveness, clarifying reliance on one adequate and well-controlled investigation with confirmatory evidence.
US Federal Register - FDA Guidance Notices · United StatesGuidance: Archiving and retention of clinical trial records
Guidance on clinical trial record retention and archiving requirements covering ownership, data integrity, and transitional provisions.
UK MHRA · UKPharmacokinetics in Patients With Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosage; Draft Guidance for Industry
FDA announces draft guidance on designing and analyzing pharmacokinetic studies in hepatically impaired patients, withdrawing the 2003 version.
US Federal Register - FDA Guidance Notices · United StatesPsychedelic Drugs: Considerations for Clinical Investigations; Guidance for Industry
FDA finalizes guidance on clinical trial design and conduct for psychedelic drug development in psychiatric and substance use disorder treatment.
US Federal Register - FDA Guidance Notices · United StatesQuantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials; Draft Guidance for Industry
FDA draft guidance on applying quantitative systems pharmacology modeling to determine starting doses in first-in-human trials for drugs and biologics.
US Federal Register - FDA Guidance Notices · United StatesMedicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Federal Anti-Kickback Statute and Beneficiary Inducements CMP
HHS seeks public input on safe harbor and exception modifications for remuneration to clinical trial participants under anti-kickback and beneficiary inducement rules.
US Federal Register - HHS Rules · United StatesClinical trials for medicines: MHRA phase I accreditation scheme
Guidance on how to join the MHRA's phase I accreditation scheme for clinical trials of medicines.
UK MHRA · UKVoluntary data submission pilot to advance innovative alternatives to animal testing
EMA launches voluntary pilot for sharing data from New Approach Methodologies to replace or reduce animal testing in non-clinical medicine development.
EMA - European Medicines Agency · EU-wideGuidance: Regulatory considerations for therapeutic use of bacteriophages in the UK
Clarifies which regulatory guidelines apply to the development of phage therapeutic products in the UK.
UK MHRA · UKACT EU: Consolidated advice on clinical trials
Two pilot initiatives launched to coordinate scientific advice between clinical trial approval and design, and pre-clinical trial application regulatory advice, continuing into 2026.
ACT EU - Accelerating Clinical Trials · EU-wideKey guidance documents for the Clinical Trials Regulation
Guidance documents supporting the Clinical Trials Regulation, which governs investigational medicinal product trials in the EU.
EC Clinical Trials · EU-wideGuidance: Clinical trials for medicines: Archiving and retention of clinical trial records
Guidance on clinical trial record retention and archiving requirements including ownership, data integrity, and transitional provisions.
UK MHRA · UKGuidance: Clinical trials for medicines: Declaration of Helsinki and Clinical Trial Regulations alignment
Guidance clarifying how amended UK clinical trial legislation aligns with the Declaration of Helsinki, with UK law taking precedence in conflicts.
UK MHRA · UKClinical trials for medicines: Good clinical practice inspections
Information relating to good clinical practice (GCP) inspections.
UK MHRA · UKClinical trials for medicines: collection, verification and reporting of safety events
Guidance on procedures for collecting, verifying and reporting safety events in investigational medicinal product trials.
UK MHRA · UKClinical trials for medicines: Compliance with ICH E6 good clinical practice (GCP) in the United Kingdom
Guidance on implementation and enforcement of ICH E6(R3) good clinical practice principles in UK clinical trial legislation.
UK MHRA · UKClinical trials for medicines: guidance on compliance with ICH E6 good clinical practice (GCP) in the United Kingdom
Guidance on how ICH E6(R3) good clinical practice principles are implemented and enforced under UK clinical trial legislation.
UK MHRA · UKGuidance: International Council for Harmonisation (ICH) E6R3 Annotations
Guidance on compliance with ICH E6(R3) good clinical practice standards for clinical trials conducted in the UK.
UK MHRA · UKGuidance: Common issues identified during clinical trial applications
Guidance identifying common validation and assessment issues in clinical trial applications and how to avoid them.
UK MHRA · UKGuidance: Declaration of Helsinki and Clinical Trial Regulations alignment
MHRA guidance on alignment of amended UK clinical trial legislation with the Declaration of Helsinki, with UK law taking precedence in conflicts.
UK MHRA · UKGuidance: Clinical Trials Regulations enforcement provisions
Guidance on expanded enforcement provisions, offences, and compliance requirements for sponsors and investigators under Clinical Trials Regulations.
UK MHRA · UKCancer Clinical Trial Eligibility Criteria: Performance Status; Guidance for Industry, Institutional Review Boards, and Clinical Investigators
FDA finalizes guidance recommending expansion of cancer clinical trial eligibility criteria to include patients with wider range of performance status.
US Federal Register - FDA Guidance Notices · United StatesCancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications; Guidance for Industry, Institutional Review Boards, and Clinical Investigators
FDA finalizes guidance on washout periods and concomitant medication exclusions in cancer clinical trial eligibility criteria.
US Federal Register - FDA Guidance Notices · United StatesCancer Clinical Trial Eligibility Criteria: Laboratory Values; Guidance for Industry, Institutional Review Boards, and Clinical Investigators
FDA finalizes guidance on selecting laboratory values as cancer trial eligibility criteria to avoid unjustified participant exclusions.
US Federal Register - FDA Guidance Notices · United StatesUK Clinical Trials Reform: Combined Review process
New streamlined Combined Review process for clinical trials with single application, 100-day maximum review timeline, and mandatory trial registration and results publication.
UK Health Research Authority · UK
Showing 50 of 101 tracked updates
Health-tech only
See all in the feed →