How medicines and medical devices get approved in European Union

One application to the European Medicines Agency leads to one marketing authorisation valid in every EU country. The agency's committee for human medicines gives an opinion within 210 active days. The European Commission then takes the binding decision.

Full application, new active substance · target 210 days · verified October 3, 2026

A full application through the European Medicines Agency for a product whose active substance is already known in the EU. New fixed combinations of known substances also use this type of application, with new data on the combination. The review steps and the 210-day opinion limit are the same as for new active substances.

Full or mixed application, known active substance · target 210 days · verified October 3, 2026

An application based mainly on published scientific literature for an active substance with at least ten years of well-established medicinal use in the EU. When it goes through the European Medicines Agency, the standard centralised steps and the 210-day opinion limit apply.

Well-established use · target 210 days · verified October 3, 2026

For medicines of major public health interest, in particular therapeutic innovation, the committee for human medicines can shorten its review from 210 to 150 days. The applicant asks for it before submitting the application.

Priority or accelerated review · target 150 days · verified October 3, 2026

The EU can authorise a medicine for a seriously debilitating or life-threatening disease before comprehensive clinical data are available, if the benefit of immediate availability outweighs the risk. The holder must complete studies to confirm the benefit. The authorisation lasts one year and is renewed each year.

Conditional or accelerated approval · target 210 days · verified October 3, 2026

The EU can authorise a medicine when comprehensive data on efficacy and safety can never be collected, for example because the disease is very rare. The authorisation carries conditions that are reassessed every year. It normally does not become a standard authorisation.

Approval under exceptional circumstances · target 210 days · verified October 3, 2026

PRIME is a European Medicines Agency scheme that gives early and enhanced support to developers of medicines that target an unmet medical need. Support includes early appointment of a rapporteur, iterative scientific advice and a submission readiness meeting. Products in PRIME can expect to be eligible for accelerated assessment.

Intensive development support designation · verified October 3, 2026

A sponsor can ask for orphan designation for a medicine for a life-threatening or chronically debilitating condition that affects no more than 5 in 10,000 people in the EU, or where sales are unlikely to cover the investment. The Committee for Orphan Medicinal Products gives an opinion within 90 days, and the Commission decides within 30 days. Incentives include protocol assistance, fee reductions and ten years of market exclusivity.

Orphan or rare disease designation · target 90 days · verified October 3, 2026

Applications for new medicines must include results of an agreed paediatric investigation plan, or a waiver or deferral. The Paediatric Committee gives its opinion on a proposed plan within 60 days. Completing an agreed plan can earn a six-month extension of the supplementary protection certificate, or two extra years of market exclusivity for orphan medicines.

Pediatric plan or incentive · target 60 days · verified October 3, 2026

Used to get the same national marketing authorisation in several EU countries at once for a medicine not yet authorised in any of them. One reference member state leads the assessment and the other countries comment and approve. The procedure lasts up to 210 days plus clock stop, followed by 30 days for national decisions.

Work-sharing or joint review · target 210 days · verified October 3, 2026

Used when a medicine already has a national marketing authorisation in one EU country and the holder wants it in other countries. The other countries recognise the existing authorisation based on the reference country's assessment report. Approval takes up to 90 days, then 30 days for national decisions.

Reliance route, recognition or verification · target 90 days · verified October 3, 2026

A medicine outside the mandatory centralised scope can be authorised in a single EU country by its national agency. EU law sets a maximum of 210 days after a valid application. If the same medicine is under review or authorised in another EU country, the decentralised or mutual recognition procedure must be used instead. National fees and details are set by each country.

Other route · verified October 3, 2026

A biosimilar is a biological medicine highly similar to a reference biological medicine already approved in the EU. The applicant shows similarity through comparability studies and adds the non-clinical and clinical data needed for the differences. The European Medicines Agency reviews it under the same 210-day opinion limit.

Biosimilar application · target 210 days · verified October 3, 2026

A generic application relies on the data of a reference medicine and shows bioequivalence. The European Medicines Agency assesses it when the reference medicine was centrally authorised or the generic brings a significant advantage. Most other generics are authorised nationally.

Generic application · target 210 days · verified October 3, 2026

A hybrid application relies partly on the data of a reference medicine and partly on new studies. It is used when a product is close to a reference medicine but differs, for example in strength, route of administration or indication. Through the European Medicines Agency, the same 210-day opinion limit applies.

Full or mixed application, known active substance · target 210 days · verified October 3, 2026

Every marketing authorisation states whether the medicine needs a prescription. A medicine can be classified as not subject to prescription when it does not meet the prescription criteria. When a switch is approved on the basis of significant new tests or trials, those data are protected for one year against other applicants seeking the same switch. Most non-prescription medicines are authorised at national level.

Non-prescription application · verified October 3, 2026

Gene therapies, somatic cell therapies and tissue engineered products must use the centralised procedure. The Committee for Advanced Therapies prepares the draft opinion, and the committee for human medicines adopts the final opinion. The European Commission decides.

Full application, new active substance · target 210 days · verified October 3, 2026

When a device includes a substance that would be a medicine on its own and supports the device's action, the device is class III. The notified body must ask a medicines authority, or the European Medicines Agency, for a scientific opinion on the substance. The authority gives its opinion within 210 days of receiving all documents.

Device: conformity assessment by a certification body · verified October 3, 2026

When a device and a medicine form a single integral product meant only for use in that combination and not reusable, such as a prefilled syringe, the whole product is authorised under medicines law. The device part must meet the general safety and performance requirements of the medical devices regulation. If the device alone would need a notified body, the dossier includes a notified body opinion on the device part.

Other route · target 210 days · verified October 3, 2026

Makers of class I medical devices declare conformity themselves after preparing the technical documentation. No notified body is involved, except for sterile, measuring and reusable surgical class I devices. The device is registered in the EU database before it is placed on the market.

Device: exempt or self-declared · verified October 3, 2026

Class I devices that are sterile, have a measuring function or are reusable surgical instruments need limited notified body involvement. The notified body checks only sterility, metrology or reuse aspects, under Annex IX Chapters I and III or Annex XI Part A.

Device: conformity assessment by a certification body · verified October 3, 2026

Class IIa devices need a notified body. The usual route is a quality management system audit with assessment of the technical documentation for at least one representative device per category. An alternative route combines technical documentation with product conformity verification.

Device: conformity assessment by a certification body · verified October 3, 2026

Class IIb devices need a notified body audit of the quality management system and assessment of technical documentation. For most class IIb implantable devices, the technical documentation of every device is assessed. Class IIb active devices that administer or remove medicines go through an extra expert panel consultation.

Device: conformity assessment by a certification body · verified October 3, 2026

Class III devices need a full notified body assessment, with the technical documentation of each device reviewed. Clinical investigations are generally required for class III and implantable devices. For class III implantable devices, the notified body consults an expert panel on its clinical evaluation assessment.

Device: conformity assessment by a certification body · verified October 3, 2026

Makers of class A in vitro diagnostic devices declare conformity themselves after preparing the technical documentation. Class A devices sold sterile need a notified body for the sterility aspects.

Device: exempt or self-declared · verified October 3, 2026

Class B in vitro diagnostic devices need a notified body audit of the quality management system and assessment of technical documentation for at least one representative device per category of devices. Self-tests and near-patient tests also get a technical documentation assessment.

Device: conformity assessment by a certification body · verified October 3, 2026

Class C in vitro diagnostic devices need a notified body audit of the quality management system and assessment of technical documentation for at least one representative device per generic device group. Self-tests and near-patient tests also get a technical documentation assessment. Companion diagnostics also need a medicines authority opinion.

Device: conformity assessment by a certification body · verified October 3, 2026

Class D in vitro diagnostic devices get the strictest assessment. The notified body reviews the quality system and technical documentation. Where an EU reference laboratory is designated, it verifies the claimed performance by laboratory testing and gives a scientific opinion within 60 days. For a first certification without common specifications, expert panels review the performance evaluation.

Device: conformity assessment by a certification body · verified October 3, 2026

Software is a medical device when the maker intends it for a medical purpose. It follows the same rules as other devices or IVDs. Rule 11 places software that informs diagnosis or treatment decisions in class IIa, IIb or III by the possible impact on health, and other software in class I. The class then decides the conformity assessment route.

Device: conformity assessment by a certification body · verified October 3, 2026