Medical devices | European Medicines Agency (2024)

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

Theconformity assessmentusually 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 Statesdesignate accreditednotified bodiesto conduct conformity assessments.

For certain high-risk devices, notified bodies must request an opinion from specific expert panels before issuing a CE certificate. These expert panels benefit from EMA's technical and scientific support.

In some cases, thenotified bodymust seek a scientific opinion fromEMAbefore issuing a CE certificate.

EMA has different regulatory responsibilitiesfor different categories of medical device, including in vitro diagnostics:

• Consultation procedure for ancillary medicinal substances in medical devices
• Consultation procedures for high-risk medical devices

The Regulations onMedical Devices (Regulation (EU) 2017/745) and onIn Vitro Diagnostic Devices (Regulation (EU) 2017/746)changed the European legal framework for medical devices, introducing new responsibilities forEMAand national competent authoritiesin the assessment of certain categories of medical device.

• The Medical Devices Regulationapplies since26 May 2021. Manufacturers must comply with the Regulation when placing new medical devices on the market. It repealsDirective 93/42/EEC on medical devicesand the Directive 90/385/EEC on active implantable medical devices.
• TheIn Vitro Diagnostic Devices Regulation appliessince26 May 2022. It repeals Directive 98/79/EC of the European Parliament and of the Councilon 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 EMAmainlyprovides scientific opinions to notified bodies throughconsultation procedures.

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

EMAcanonly addressquestions 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 devicein 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 productsthat 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 theQ&A on the implementation of the Medical Device Regulation and In Vitro Diagnostic Devices Regulation.

A medical devicemay contain an ancillary medicinal substanceto 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 scientificopinion from EMA on the quality and safety of the ancillary substance if itis 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 authorityor from EMAe.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:

• Ancillary medicinal substances in medical devices

A companion diagnostic is anin vitro diagnostic test that supports the safe and effective use of aspecific medicinal product, byidentifyingpatients that are suitable or unsuitable fortreatment.

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 Regulationapplies 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 scientificopinion from EMAon thesuitability 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 forthe medicinal product has been submitted through the centralised procedure.

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

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

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

The FAQ document below provides an overview of EMA’s line of thinking on issues related to predictive biomarker-guided medicinal product development and assessment involving companion diagnostic (CDx).

For more information:

• Full list of procedural timetables

Some medical devices are made of substances that are absorbed by the human bodyto 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, thenotified body mustseek ascientific opinionfrom 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 orEMA.

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 medicinesand food supplements.

National competent authorities classify borderline products either asmedicinal 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 EMAon 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, theRegulations onMedical Devices (Regulation (EU) 2017/745) and onIn Vitro Diagnostic Devices (Regulation (EU) 2017/746)require notified bodiesto consultexpert panels before issuing a CE certificate.

These high-risk medical devices include:

• Class III implantable devices and class IIbactive devices that areintended toadminister or remove medicinal products from the body
• Class D in vitrodiagnostic medical devices

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 thePECP

In line with the RegulationonMedical Devices,the expert panels havestarted 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 advisethe European Commission,national competent authorities in EU Member Statesand notified bodies, if needed.

The implementation of these activities is gradual. EMA will provide further information for stakeholderswhen 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 theRegulation onEMA's Reinforced Role(Regulation(EU) 2022/123). For more information, seeCrisis preparedness and management.

EMA is runninga pilot that enables the expert panels to providescientific advice formanufacturers of high-risk medical devices.

For more information on the pilot, including related presentations and a letter of interesttemplate 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 invitesEU-based manufacturers or their authorised representatives to apply for a third phase of the pilot by30 June 2024.They can use the following application form:

• Scientific advice pilot application form

For the third pilot phase, applicants can indicate if they would be willing to have an HTA body observe their project. In such cases, EMA will inform them whether this will be possible.

Applicants can address any questions tothe expert panelsecretariat ateu-operations-expamed@ema.europa.eu.

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

EMA will publish further information on the pilot's progress, including its second round, in due course.

As the current pilot phaseincludesa limitednumber of scientific advice procedures, the expert panelsprioritise applications that can cover varied medical areas and device types.

Experts uphold three prioritisation criteria:

• devices usedby a relatively small group of patients to help diagnose or treat a disease or condition- for instance, so-calledorphan devicesand those for paediatricuse;
• devices that help addressunmet 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 devicesthat can have a major clinical or health impact.

Applications from smallandmedium-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 advicefor medical devices refers tointended clinical development strategies and clinical investigationproposals. It covers:

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