Medical devices are products or equipment intended generally for a medical use. They are regulated by national competent authorities, but the European Medicines Agency (EMA) is also involved in the assessment of certain categories of medical device under European Union (EU) legislation.
Medical devices in the EU have to undergo a conformity assessment to demonstrate that they meet legal requirements to ensure they are safe and perform as intended. EU Member States can designate accredited notified bodies to conduct conformity assessments.
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.
Manufacturers can place a CE (Conformité Européenne) mark on a medical device once it has passed a conformity assessment.
The adoption of Regulation (EU) 2017/745 on Medical Devices (MDR) and Regulation (EU) 2017/746 on In-Vitro Diagnostic Devices (IVDR) changed the European legal framework for medical devices, introducing new responsibilities for EMA and for national competent authorities. Both Regulations entered into force in May 2017 and have a staggered transitional period.
The MDR has a transition period of three years and will fully apply from 26 May 2020. The IVDR has a transition period of five years and will fully apply from 26 May 2022.
During the transition period, manufacturers can place devices on the market under the currently applicable EU Directives (93/42/EEC, 98/79/EC and 90/385/EEC) or under the new Regulations if they fully comply with these.
The sections below describe the new and revised responsibilities of the Agency in relation to different categories of medical device.
Medicines can be marketed for use in combination with a medical device, usually to enable the delivery of the medicine.
If the principle intended action of the combination product is achieved by the medicine, the entire product is regulated as a medicinal product under Directive 2001/83/EC or Regulation (EC) No 726/2004.
There are two types of combination:
- integral: the medicinal product and device form a single integrated product e.g. pre-filled syringes and pens, patches for transdermal drug delivery and pre-filled inhalers;
- co-packaged: the medicinal product and the device are separate items contained in the same pack e.g. reusable pen for insulin cartridges, tablet delivery system with controller for pain management.
The regulatory requirements for the medical device differ depending on whether or not it is integral.
Medical devices that are co-packaged or obtained separately must be CE marked in accordance with the medical device legislation.
Article 117 of the MDR introduces a new requirement for medicines with an integral device. The marketing authorisation application should include a CE certificate or declaration of conformity for the device or, if it is not CE marked but would need to be certified if marketed separately, the applicant must include an opinion from a notified body on the conformity of the device. For further information, see:
- Questions and answers on implementation of the medical devices and in vitro diagnostic medical devices Regulations ((EU) 2017/745 and (EU) 2017/746)
- Questions and answers on implementation of the medical devices and in vitro diagnostic medical devices Regulations ((EU) 2017/745 and (EU) 2017/746) - tracked changes
On 3 June 2019 EMA released for public consultation a guideline on quality requirements for regulatory submissions for medicines that include a medical device (drug-device combinations). The device can be integral, co-packaged or obtained separately:
The guideline clarifies expectations laid down in Directive 2001/83/EC and addresses the new obligations in Regulation (EU) 2017/745, in particular the requirements under Article 117 (see above).
The public consultation will last until 31 August 2019. Stakeholders are invited to send their comments to email@example.com using the template provided.
EMA intends to finalise the guideline before the regulation fully applies on 26 May 2020.
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.
If the ancillary substance is derived from human blood or human plasma, or if it is within the scope of the centralised procedure for the authorisation of medicines, the notified body must seek a scientific opinion from EMA on the quality and safety of the ancillary substance before it can issue a CE certificate.
For other substances, the notified body can seek the opinion of a national competent authority or EMA e.g. in cases where the Agency has already evaluated a medicine containing the same medicinal substance.
For information on the consultation procedure to seek an EMA scientific opinion, see Consultation procedure for ancillary medicinal substances in medical devices.
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 and condoms coated with spermicides.
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 regulation (IVDR) introduces a new classification system for companion diagnostics and the obligation to undergo a conformity assessment by a notified body.
Some medical devices are made of substances that are absorbed by the human body to achieve their intended purpose.
These invasive devices are normally introduced into the human body via an orifice or applied to the skin.
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.
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.
The new medical device legislation foresees that the European Commission may consult EMA’s scientific committees 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.