The European Union (EU) has developed a complex, hierarchical legislative framework to regulate clinical research involving medicinal products and medical devices. This framework ensures harmonised standards for safety, ethics, transparency, and scientific validity across Member States, while allowing for national flexibility where appropriate.
Its core instruments include Regulations, which apply directly in all EU countries, and Directives, which must be transposed into national law.
Executive summary
Clinical trials of medicinal products are now centrally governed by Regulation (EU) No 536/2014 (the Clinical Trials Regulation, or CTR), which replaced the older Directive 2001/20/EC. This regulation mandates the use of the Clinical Trials Information System (CTIS) and standardises the authorisation, conduct, and transparency of trials.
Medical device studies, including diagnostics, are regulated under two newer frameworks: Regulation (EU) 2017/745 (the Medical Devices Regulation, or MDR) and Regulation (EU) 2017/746 (the In Vitro Diagnostic Regulation, or IVDR). These introduce stricter requirements for clinical evaluation and provide unified oversight mechanisms.
Cross-cutting regulations, such as the General Data Protection Regulation (GDPR), and international ethical guidelines (e.g., the Declaration of Helsinki) also play relevant roles in trial compliance, particularly in the areas of data handling and patient rights.
Layers of EU law
The EU regulatory framework for clinical research is composed of different types of legal and interpretative instruments. These vary in their legal force, scope of application, and implementation mechanisms. The table below summarises the main categories, highlighting their status, how they are applied across Member States, and typical examples relevant to medicinal products and medical devices
| Instrument | Legal status | Application level | Example |
|---|---|---|---|
| Regulation | Legally binding in their entirety and directly applicable in all Member States without the need for national transposition | Directly applicable in all Member States | e.g., Regulation (EU) 536/2014 (CTR) |
| Directive | Binding with respect to the intended result, but Member States have discretion in how to implement them through their own national laws; this allows adaptation to national legal systems while achieving harmonised outcomes | Transposed into national law | e.g., Directive 2001/83/EC |
| Guidance Document | Not legally binding, but reflect how regulatory authorities interpret and apply legal provisions | EU-wide (interpretative aid) | e.g., EMA Q&A docs |
| ICH Guideline | Non-binding at the global level, ICH guidelines are adopted regionally and are often integrated into EU law or formally adopted by the European Medicines Agency (EMA) | Incorporated into EU guidance or law | e.g., ICH GCP E6 and E8 used in EMA/Commission practices |
EU Regulations vs EU Directives
The EU regulatory environment consists of several hierarchically interacting layers, particularly distinguishing between EU-wide rules (Regulations) and nationally adapted rules (Directives).
| Regulations | Directives | |
|---|---|---|
| What it is | A regulation is a directly binding law | A directive is a goal or framework the EU gives to its member countries |
| How it works | Applies in all EU countries immediately and identically | Member States must implement it through national legislation |
| Binding status | Fully binding as written | Binding in goal, not form |
| Applies to | All EU countries immediately | EU countries must transpose it into national law |
| National law? | Not needed | Required |
| Uniformity | Identical in all countries | May differ across countries |
Reference grid of key legislation
Clinical trials (medicinal products)
The following table outlines key EU legal acts governing medicinal products and clinical research. It includes both Regulations, which are directly applicable across all Member States, and Directives, which require national transposition. These instruments cover core areas such as marketing authorisation, clinical trials, good clinical practice (GCP), and special categories like paediatrics and advanced therapies.
| ID | Year | Title | Description |
|---|---|---|---|
| Regulation (EEC) No 1768/92 | 1992 | Supplementary Protection Certificate (SPC) | Market exclusivity after patent + regulatory delay |
| Directive 2001/83/EC | 2001 | Community Code on medicinal products | Defines what a medicinal product is; interface with MA and safety systems |
| Regulation (EC) No 726/2004 | 2004 | Establishes EMA and centralised Marketing Authorisation (MA) procedure | Controls centrally authorised products and role of EMA |
| Directive 2005/28/EC | 2005 | GCP principles and IMP guidance | Supplements CTR; remains relevant for GCP detail and non-interventional trials |
| Regulation (EC) No 1901/2006 | 2006 | Paediatric Regulation | Requires Paediatric Investigation Plans (PIP) as part of MA process |
| Regulation (EC) No 1902/2006 | 2006 | Amendments to Paediatric Regulation | Technical amendments |
| Regulation (EC) No 1394/2007 | 2007 | Advanced Therapy Medicinal Products (ATMP) | Applies to gene, cell, and tissue-engineered products |
| Regulation (EU) No 536/2014 | 2014 | Clinical Trials Regulation (CTR) | Current law on interventional trials for medicinal products; replaces Directive 2001/20/EC |
Medical devices and device-based studies
The table below summarises key EU legislative acts relevant to medical devices.
| ID | Year | Title | Description |
|---|---|---|---|
| Directive 2001/20/EC | 2001 | Clinical Trials Directive | Repealed by CTR but still referenced in transition and historical context |
| Directive 2004/23/EC | 2004 | Human tissues and cells | Cross-relevant for ATMP and transplantation studies |
| Regulation (EU) 2017/745 | 2017 | Medical Devices Regulation (MDR) | Fully applicable since May 2021. Governs all medical device trials. Replaces MDD (93/42/EEC) |
| Regulation (EU) 2017/746 | 2017 | In Vitro Diagnostic Devices Regulation (IVDR) | Fully applicable since May 2022 |
Cross-cutting legislation
| ID | Year | Title | Description |
|---|---|---|---|
| Directive 95/46/EC | 1995 | Data protection (repealed) | Historical only, replaced by GDPR |
| Regulation (EU) 2016/679 | 2016 | General Data Protection Regulation (GDPR) | Applies to all personal data in clinical and device trials; crucial for consent and privacy |
| Ethics & Human Rights Docs | — | Helsinki declaration, Oviedo convention (European bioethics convention), etc | Not EU law but used for ethical standards in consent, vulnerable subjects, etc |
See also
Another relevant pages
Links to this page
References and notes
External links