Medical devices

Medical devices are products or equipment intended for a medical purpose. In the European Union (EU) they must undergo a conformity assessment to demonstrate they meet legal requirements to ensure they are safe and perform as intended. They are regulated at EU Member State level, but the European Medicines Agency (EMA) is involved in the regulatory process.

Manufacturers can place a CE (Conformité Européenne) mark on a medical device once it has passed a conformity assessment.

The conformity assessment usually involves an audit of the manufacturer's quality system and, depending on the type of device, a review of technical documentation from the manufacturer on the safety and performance of the device.

EU Member States designate accredited notified bodies to conduct conformity assessments. For certain high-risk devices, notified bodies shall request the opinion of specific expert panels before issuing the certificate of conformity. These expert panels benefit from EMA's technical and scientific support. 

In some other cases, the notified body must seek a scientific opinion from EMA before issuing a CE certificate.

EMA has distinct regulatory responsibilities per category of medical device, including in vitro diagnostics. They are as follows:

• Medicines used in combination with a medical device ─ EMA assesses the safety and effectiveness of medicines used in combination with a medical device. This is part of a centralised procedure application for the medicinal product.
• Medical devices with an ancillary medicinal substance ─ the notified body must seek EMA's scientific opinion on the quality, safety, and usefulness of the ancillary medicinal substance in three cases: if the ancillary substance is derived from human blood or plasma; if it has been previously evaluated by the EMA; or if it falls within the mandatory scope of the centralised procedure.
• Companion diagnostics ('in vitro diagnostics') ─ the notified body must seek EMA's scientific opinion on the suitability of the companion diagnostic to the medicinal product if the latter falls within the scope of the centralised procedure.
• Medical devices made of substances that are systemically absorbed ─ the notified body must seek the scientific opinion of a competent authority. The EMA provides scientific opinions on the compliance of the substance with the requirements laid down in Annex I to Directive 2001/83/EC.
• High-risk medical devices ─ EMA supports the medical device expert panels that provide opinions and views to notified bodies on the scientific assessment of certain high-risk medical devices and in vitro diagnostics.

The Regulations on Medical Devices (Regulation (EU) 2017/745) and on In Vitro Diagnostic Devices (Regulation (EU) 2017/746) changed the European legal framework for medical devices, introducing new responsibilities for EMA and national competent authorities in the assessment of certain categories of medical device. 

The Medical Devices Regulation applies since 26 May 2021. Manufacturers must comply with the Regulation when placing new medical devices on the market. It repeals Directive 93/42/EEC on medical devices and the Directive 90/385/EEC on active implantable medical devices.

The In Vitro Diagnostic Devices Regulation applies since 26 May 2022. It repeals Directive 98/79/EC of the European Parliament and of the Council on in vitro diagnostic medical devices.

Question-and-answer guidance on the implementation of these Regulations is available below.

According to the current medical devices legislative framework, the EMA mainly provides scientific opinions to notified bodies through consultation procedures.

EMA's regulatory role is limited to the assessment of certain categories of medical devices and in vitro diagnostics, and in the context of medicinal products used in combination with a medical device.

EMA can only address questions under its remit.

Some medicines are used in combination with a medical device, usually to enable the delivery of the medicine.

If the principal intended action is achieved by the medicine, it is considered a medicinal product that includes a medical device.

The entire product is regulated under EU pharmaceutical legislation (Directive 2001/83/EC or Regulation (EC) No 726/2004) and must obtain a marketing authorisation for a medicinal product.

The device part of the combination may require a conformity assessment, as follows:  

Role of EMA

EMA is responsible for evaluating the quality, safety and efficacy of marketing authorisation applications assessed through the centralised procedure, including the safety and performance of a medical device in relation to its use with a medicinal product. 

The medical device may be co-packaged with, obtained separately from or integral to the medicinal product. 

EMA issued a final guideline on quality documentation for medicinal products that include a medical device in July 2021. This clarifies expectations laid down in Directive 2001/83/EC and addresses obligations in the Medical Devices Regulation, in particular under Article 117. 

EMA recommends reading the guideline in conjunction with the Q&A on the implementation of the Medical Device Regulation and In Vitro Diagnostic Devices Regulation. 

A medical device may contain an ancillary medicinal substance to support the proper functioning of the device. These products fall under the medical devices legislation and must be CE marked.

Examples of medical devices with an ancillary medicinal substance include:

• drug-eluting stents;
• bone cement containing an antibiotic;
• catheters coated with heparin or an antibiotic agent;
• condoms coated with spermicides.

Role of EMA

Before it can issue a CE certificate, the notified body must seek a scientific opinion from EMA on the quality and safety of the ancillary substance if it is derived from human blood or human plasma, or if it is within the scope of the centralised procedure for the authorisation of medicines.

For other substances, the notified body can seek the opinion from a national competent authority or from EMA e.g. in cases where EMA has already evaluated a medicine containing the same medicinal substance.

EMA publishes consultation procedure public assessment reports (CPAR) on its scientific opinions.

For information on the consultation procedure to seek an EMA scientific opinion, see:

• Consultation procedure for ancillary medicinal substances in medical devices

A companion diagnostic is an in vitro diagnostic test that supports the safe and effective use of a specific medicinal product, by identifying patients that are suitable or unsuitable for treatment. 

The In Vitro Diagnostic Devices Regulation (Regulation (EU) 2017/746) introduces a new classification system for companion diagnostics and the obligation to undergo a conformity assessment by a notified body. 

The Regulation applies from 26 May 2022, following a five-year transition period.

Role of EMA

Before it can issue a CE certificate, the notified body must seek a scientific opinion from EMA on the suitability of the companion diagnostic to the medicinal product concerned if: 

• the medicinal product falls exclusively within the scope of the centralised procedure for the authorisation of medicines, or
• the medicinal product is already authorised through the centralised procedure, or
• a marketing authorisation application for the medicinal product has been submitted through the centralised procedure.

For other substances, the notified body can seek the opinion from a national competent authority or EMA.

A guidance document is available on the consultation procedure whereby notified bodies seek a scientific opinion from EMA. This is joined by a question-and-answer (Q&A) document on practical arrangements.

This guidance should help notified bodies, device manufacturers and medicinal product applicants understand the procedural aspects of the consultation process.

Notified bodies should use the application forms below to request an initial or follow-up consultation.

For more information:

• Full list of procedural timetables

Some medical devices are made of substances that are absorbed by the human body to achieve their intended purpose.

These devices are normally introduced into the human body via an orifice or applied to the skin.

Role of EMA

Before it can issue a CE certificate, the notified body must seek a scientific opinion from EMA or a national competent authority on the compliance of the substance with the requirements laid down in Annex I to Directive 2001/83/EC.

EMA will provide further information on the consultation procedure between the notified body and a competent authority or EMA. 

Borderline products are complex healthcare products for which there is uncertainty over which regulatory framework applies. 

Common borderlines are between medicinal products, medical devices, cosmetics, biocidal products, herbal medicines and food supplements.

National competent authorities classify borderline products either as medicinal products or, for example, as medical devices on a case-by-case basis. This determines the applicable regulatory framework. 

Applicants who are unclear on the correct classification of their product should consult a national competent authority and provide information on the product's composition and constituents, a scientific explanation of the mode of action and its intended purpose.

Role of EMA

The Medical Devices Regulation foresees that the European Commission may consult EMA on products that borderline with medicines.

EMA's Innovation Task Force provides advice to medicine developers on eligibility to EMA procedures relating to the research and development of borderline products.

For certain high-risk devices, the Regulations on Medical Devices (Regulation (EU) 2017/745) and on In Vitro Diagnostic Devices (Regulation (EU) 2017/746) require notified bodies to consult expert panels before issuing a CE certificate.

These high-risk medical devices include:

• Class III implantable devices and class IIb active devices that are intended to administer or remove medicinal products from the body
• Class D in vitro diagnostic medical devices

The expert panels can provide:

• opinion on the notified body’s assessment of the manufacturer’s clinical file of the above-mentioned class III and class IIb medical devices (the clinical evaluation consultation procedure (CECP));
• views on the manufacturer’s performance evaluation report of class D in vitro diagnostic medical devices (the performance evaluation consultation procedure (PECP)).

The expert panels' opinions and views are currently available on the European Commission's website:

• European Commission: List of opinions on class III implantable devices and class IIb devices under the CECP
• European Commission: List of views on class D devices under the PECP

In line with the Regulation on Medical Devices, the expert panels have started to provide advice to the Medical Device Coordination Group (MDCG). This advice is currently available on the European Commission's website.

They are also foreseen to advise the European Commission, national competent authorities in EU Member States and notified bodies, if needed. 

The implementation of these activities is gradual. EMA will provide further information for stakeholders when available.

For more information, see:

• European Commission: Medical devices expert panels: Overview 

Role of EMA

EMA provides administrative, technical and scientific support to the expert panels, in accordance with the Regulation on EMA's Reinforced Role (Regulation (EU) 2022/123). For more information, see Crisis preparedness and management.

EMA is running a pilot that enables the expert panels to provide scientific advice for manufacturers of high-risk medical devices.

For more information on the pilot, including related presentations and a letter of interest template that can serve as guidance for applicants, see:

• Information session on the pilot for expert panels’ scientific advice to manufacturers of high-risk medical devices (25/01/2023)
• EMA pilots scientific advice for certain high-risk medical devices (27/02/2023)

EMA invited EU-based manufacturers or their authorised representatives to apply for a second phase of the pilot.

Manufacturers had until 15 September 2023 to apply via EMA's ServiceNow portal (login required).

In the first round, the expert panels selected six applications focused on fields such as circulatory system, orthopaedics, neurology and dentistry.

As this pilot phase includes a limited number of scientific advice procedures, the expert panels prioritise applications that can cover varied medical areas and device types.

Experts uphold three prioritisation criteria:

• devices used by a relatively small group of patients to help diagnose or treat a disease or condition - for instance, so-called orphan devices and those for paediatric use;
• devices that help address unmet medical needs - for example, devices for medical conditions that are life threatening or can cause permanent impairment, and for which the treatment currently available is insufficient or carrying significant risks for patients;
• novel devices that can have a major clinical or health impact.

Applications from small and medium-sized enterprises (SMEs) receive special attention to ensure their representation in the pilot. 

As per the Medical Devices Regulation (Article 61(2) of Regulation (EU) 2017/745), scientific advice for medical devices refers to intended clinical development strategies and clinical investigation proposals. It covers:

• class III medical devices;
• class IIb active medical devices intended to administer or remove medicinal products from the body.