European Medicines Agency (EMA)
Last Updated: March 12th, 2026
In the European Union, new drugs and biologics are regulated separately than new medical devices and in vitro diagnostics. New drugs and biologics are regulated under the European Medicine Agency (EMA). For new medical devices and in vitro diagnostics, a declaration of conformity with the essential requirements, based on a self-assessment, are required for low risk products. For higher risk products, a Notified Body’s involvement is required.
New Drugs and Biologics – European Medicines Agency (EMA)
In the European Union, new drugs and biologics are regulated separately from new medical devices and in vitro diagnostics. New drugs and biologics are regulated under the European Medicines Agency (EMA). For new medical devices and in vitro diagnostics, a separate regulatory framework applies under the EU Medical Devices Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR), which involve conformity assessment and CE marking, often through third-party organizations called Notified Bodies.
New Drugs and Biologics – European Medicines Agency (EMA)
The European Medicines Agency (EMA) is an agency of the European Union that conducts scientific evaluation of new drugs developed by pharmaceutical companies for use in the European Union. It started operations in 1995 and is headquartered in Amsterdam, the Netherlands. (EMA was previously located in London but relocated to Amsterdam in 2019 following the United Kingdom’s departure from the European Union.)
The requirement for EMA oversight for new drugs came after EU Directive 2001/83/EC: Community Code on Medicinal Products for Human Use:
No medicinal product (with the exception, under certain conditions, of radiopharmaceuticals prepared at the time of use) may be placed on the market of a Member State unless an authorization has been issued by the competent authorities of that Member State or by the European Medicines Agency (EMA).
An authorization holder may submit a request for recognition of this authorization to other Member States.
Member States must make the wholesale distribution of medicinal products subject to the possession of an authorization to engage in activity as a wholesaler of medicinal products.
EMEA or EMA?
The original organization was set up as the European Agency for the Evaluation of Medicinal Products in 1993 under EC Regulation No. 2309/93. It was renamed in 2004 by EC Regulation No. 726/2004 to the European Medicines Agency and had the acronym EMEA until December 2009. EMA is now used. EMEA or EMA is commonly used in clinical research industry when referring to the European Medicines Agency.
How EMA Works
EMA uses a centralized approach to the review and approval of new medicinal products. Pharmaceutical companies submit one single marketing-authorization application to the EMA. An approval by the European Commission is valid in all European Union (EU) Member States and in the European Economic Area (EEA) countries: Iceland, Liechtenstein and Norway. A company can then start to market a new medicine product after it has received a marketing authorization.
EMA’s scientific evaluation is carried out mostly by its scientific committees. Scientific committees compose of members from EEA countries and representatives of patient, consumer and healthcare-professional organizations.
EU Clinical Trials Regulation
For clinical research professionals, one of the most significant recent changes in the EU regulatory landscape is the EU Clinical Trials Regulation (CTR), Regulation (EU) No. 536/2014. This regulation replaced the older Clinical Trials Directive (2001/20/EC), which had governed clinical trial conduct in the EU since 2004.
The CTR became applicable on January 31, 2022, when the European Medicines Agency launched the Clinical Trials Information System (CTIS) – a centralized online portal for submitting, assessing, and supervising clinical trials across all EU and EEA member states.
Key changes under the CTR:
Single submission portal (CTIS)Sponsors now submit one clinical trial application through CTIS to all EU/EEA countries where the trial is intended to take place. This replaced the old process of submitting separate applications to each country’s national competent authority and ethics committee.
Coordinated assessmentMember states jointly assess the application, with one designated as the “Reporting Member State” to coordinate the review. Each member state still makes its own authorization decision, but the process is harmonized and operates under defined timelines.
Increased transparencyMost clinical trial data submitted through CTIS is publicly accessible, unless specific grounds for confidentiality apply (such as personal data or commercially confidential information).
Harmonized safety reportingSuspected Unexpected Serious Adverse Reactions (SUSARs) must be reported electronically via the EudraVigilance database. Sponsors must also submit Annual Safety Reports through CTIS.
Transition completeFrom January 31, 2023, all new clinical trial applications were required to be submitted through CTIS. As of January 31, 2025, all ongoing clinical trials including those originally authorized under the old Clinical Trials Directive must be managed in CTIS and comply with the CTR.
Why this matters for CRAs:
If you work on clinical trials conducted in the EU, the CTR and CTIS directly affect your day-to-day work. Regulatory submissions, safety reporting, and trial documentation now flow through a centralized system that differs from the country-by-country approach many experienced professionals were trained on. Understanding how CTIS works and how the CTR’s requirements differ from the old Directive is increasingly important for CRAs working on global or EU-based trials.
Medical Devices & In Vitro Diagnostics
The regulatory framework for medical devices and in vitro diagnostics in the European Union has undergone a major overhaul. The three EC Directives that previously governed these products have been replaced by two new EU Regulations:
Medical Devices Regulation (MDR), EU 2017/745Replaced the Medical Devices Directive (MDD, 93/42/EEC) and the Active Implantable Medical Devices Directive (AIMDD, 90/385/EEC). The MDR has been fully applicable since May 26, 2021, though extended transition periods for certain device classes run through the end of 2028.
In Vitro Diagnostic Regulation (IVDR), EU 2017/746Replaced the In Vitro Diagnostic Directive (IVDD, 98/79/EC). The IVDR has been fully applicable since May 26, 2022, with staggered transition periods for certain product categories.
Unlike the old Directives, which were transposed into each member state’s national law with some variation, the MDR and IVDR are EU Regulations – meaning they apply directly and uniformly across all EU member states without the need for national transposition.
Key Changes Under MDR & IVDR
The new regulations impose significantly stricter requirements than the old Directives. Some of the most important changes include:
Stronger clinical evidence requirementsManufacturers must demonstrate clinical safety and performance through more rigorous clinical evaluations. For higher-risk devices, clinical investigations (clinical trials) are more commonly expected. The ability to rely solely on literature-based equivalence claims has been significantly restricted under the MDR.
Stricter classification rulesThe MDR and IVDR both introduced updated risk classification systems. Notably, the IVDR moved from a mostly self-certification model to a risk-based classification system where the majority of IVDs now require Notified Body involvement — a major change for the IVD industry.
Enhanced post-market surveillanceManufacturers are required to conduct ongoing post-market surveillance (PMS), including periodic safety update reports (PSURs) and, for higher-risk devices, post-market clinical follow-up (PMCF) studies.
Unique Device Identification (UDI)The MDR and IVDR require devices to carry a Unique Device Identifier, enabling better traceability throughout the supply chain.
EUDAMEDThe European Database on Medical Devices (EUDAMED) is being implemented to serve as a centralized system for device registration, Notified Body certificates, clinical investigations, vigilance, and market surveillance. The first four modules of EUDAMED will become mandatory from May 28, 2026.
Notified Bodies
As under the old Directives, medium- to high-risk devices and IVDs require a conformity assessment by a Notified Body, an independent third-party organization designated and audited by EU member states. However, the designation requirements for Notified Bodies have become much stricter under the MDR and IVDR. This has resulted in fewer designated Notified Bodies being available compared to the old system, which has contributed to longer review timelines and certification bottlenecks, which is a challenge the European Commission is actively working to address through proposed legislative simplifications.
CE Marking
CE marking remains the requirement for medical devices and IVDs to be marketed in the European Economic Area (EEA). The CE mark indicates that the manufacturer has demonstrated conformity with the applicable requirements of the MDR or IVDR. The fundamental concept is the same as under the old Directives – manufacturers of low-risk devices (Class I) may self-declare conformity, while higher-risk devices require Notified Body assessment, but the underlying requirements for achieving CE marking are now substantially more demanding.
Clinical Data Requirements
Whether for drugs or devices, clinical data is central to demonstrating safety and effectiveness in the EU. Under the MDR, clinical evaluations must be based on sufficient clinical evidence, which may include clinical investigation data, published literature, and/or post-market clinical follow-up data. The MDR places greater weight on clinical investigations (clinical trials in human subjects) for novel or high-risk devices compared to the old MDD, and the conditions under which a manufacturer can rely on equivalence to a predicate device have been tightened considerably.
For CRAs working on medical device or IVD clinical trials in the EU, understanding the MDR and IVDR requirements, including the specific clinical investigation procedures outlined in these regulations, is essential, as they differ in important ways from the drug trial framework under the EMA and the Clinical Trials Regulation.
Clinical Data Requirement
Whether new drugs or devices are being considered for approval under different pathways, clinical data may be necessary to demonstrate safety and effectiveness. The term clinical data under the EC Directives is a broad concept that may range from bench testing to clinical trials in human subjects.
For example, in the MDD, the clinical data used for CE marking may compose of one of the two forms:
Either a compilation of the relevant scientific literature currently available on the intended purpose of the device and the techniques employed, together with, if appropriate, a report containing a critical evaluation of the compilation
Results and conclusions of a specifically designed clinical investigation
In general, clinical trials (second option above) are usually needed for new drug and higher risk devices. However, literature route (first option above) may be used by manufacturers of low to medium risk devices, where safety and effectiveness can be shown through nonclinical data (bench testing and animal testing) and pre-existing data (scientific literatures).
European Medicines Agency (EMA) is a post from: Clinical Research Associate CRA
