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 · 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 StatesGeneral 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 · 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US Federal Register - FDA Guidance Notices · United StatesPotency Assessment of Active Immunotherapy Products; Draft Guidance for Industry
FDA announces draft guidance on designing, validating and evaluating potency assays for active immunotherapy products including peptide and protein-based ACTIMPs.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 StatesFimea 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 · FinlandGuidance: 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 · FinlandGuidance: 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 · UKUpdated 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-wideGuidance: 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 · UKGuidance: 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 · UKUK 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 · UKStakeholders' Consultation on EudraLex Volume 4 - Good Manufacturing Practice Guidelines: Chapter 4, Annex 11 and New Annex 22
Public consultation on amendments to GMP guidelines for pharmaceutical manufacturing, including Chapter 4, Annex 11, and a new Annex 22.
EC Clinical Trials · EU-wideNew two-year plan to support safe use of AI in UK health research
29 May 2026
UK Health Research Authority · UKCOMBINE Programme advances to second phase of coordinated assessment pilot project for combined clinical trials
Portugal's INFARMED announces the COMBINE programme has progressed to the second phase of its pilot project for coordinated evaluation of combined clinical trials.
Portugal INFARMED · PortugalCzech Ministry of Health presents first National Strategy for Clinical Trials and planned information portal for patients and professionals
Czech Ministry of Health adopted the first National Strategy for Clinical Trials of Human Medicinal Products 2035, aiming to improve research conditions and patient access to innovative therapies.
Czechia SUKL · Czech RepublicUpdate - Member States-specific national requirements for clinical investigations and performance studies
News announcement 21 April 2026 Update - Member States-specific national requirements for clinical investigations and performance studies Update - Member States-specific national requirements for clinical investigatio...
EC Public Health · EU-wideACT EU Multi-stakeholder platform: 2025 annual meeting report
Report from the third annual ACT EU Multi-stakeholder platform meeting (29 October 2025) summarising discussions on patient-centred research, methodologies, biotechnology, AI, digitalisation and ethics to inform workplan revision.
ACT EU - Accelerating Clinical Trials · EU-wideThe new Innovative Licensing and Access Pathway welcomes first investigational products
The UK MHRA announces the first investigational products enrolled in the Innovative Licensing and Access Pathway, enabling early-stage developer engagement with regulators and HTA bodies.
UK MHRA · UKUK clinical trial approval times twice as fast with AI and reforms
UK MHRA reports clinical trial approval times reduced from 91 to 41 days through AI and regulatory reforms.
UK MHRA · UKACT EU: Implementation of the Clinical Trials Regulation
EU regulatory network publishes statistics and progress reports on Clinical Trials Regulation implementation and CTIS usage across EU/EEA.
ACT EU - Accelerating Clinical Trials · EU-wideClinical trials analytics
ACT EU initiative to collect stakeholder use cases and research priorities for analysis of clinical trial data from regulatory registers and CTIS.
ACT EU - Accelerating Clinical Trials · EU-wideACT EU workplan for 2026-2027 and updated objectives published
ACT EU published its 2026-2027 workplan aligned with updated objectives, informed by the proposed Biotech Act, Clinical Research Investment Plan and EU4Health initiatives.
ACT EU - Accelerating Clinical Trials · EU-widePatients to benefit sooner as UK boosts clinical trials attractiveness with faster assessments and agile regulation
The MHRA is now setting out the next phase of reforms for 2026, aimed at helping patients access new cutting-edge treatments more quickly and boosting the UK’s competitiveness for global clinical research.
UK MHRA · UKMHRA launches Route B notification pilot as part of clinical trials regulations rollout
MHRA pilot programme to help sponsors prepare for new substantial modifications process under upcoming clinical trials regulations.
UK MHRA · UK
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