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.

Medical devices legislation

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.

Medicinal products used in combination with a medical device

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:  

Type of combinationIllustrationConformity assessment of device
Integral
  • Medicinal product and device form a single integrated product
  • Examples include:
    • pre-filled syringes and pens
    • patches for transdermal drug delivery
    • pre-filled inhalers
  • Marketing authorisation application should include a CE certificate for the device or, if not CE marked but would need to be certified if marketed separately, applicant must include an opinion from a notified body on conformity of device
  • Requirement applies since 26 May 2021 under article 117 of Medical Devices Regulation
  • Requirement does not apply to Class I devices (non-sterile, non-measuring)
Co-packaged or obtained separately
  • Medicinal product and device are separate items contained in same pack or obtained separately
  • Examples include:
    • reusable pen for insulin cartridges
    • tablet delivery system with controller for pain management
  • Must be CE marked in accordance with EU medical devices legislation

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. 

Medical devices with an ancillary medicinal substance

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:

Companion diagnostics ('in vitro diagnostics')

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: 

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.

    Medical devices made of substances that are systemically absorbed

    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

    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.

    High-risk medical devices (updated)

    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 available on the European Commission's website:

    Update: EMA will launch a pilot enabling the expert panels to provide scientific advice for manufacturers of high-risk medical devices.

    As per the Medical Devices Regulation (Article 61(2) of Regulation (EU) 2017/745), this type of scientific advice refers to intended clinical development strategies and clinical investigation proposals. It covers class III medical devices and class IIb active medical devices intended to administer or remove medicinal products from the body.

    The pilot is expected in February 2023.

    By the time of the launch, EMA will provide further information on related criteria for selection, templates for submission and timelines.

    For more information, see:

    In line with the Regulation on Medical Devices, the expert panels have already started to provide ad hoc advice to the Medical Device Coordination Group (MDCG).

    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:

    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.

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