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Medical devices are products or equipment intended generally for a medical use and are regulated at Member State level. 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 the European Medicines Agency (EMA) and national competent authorities in the assessment of certain categories of medical device.
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 Medical Devices Regulation (Regulation (EU) 2017/745) applies from 26 May 2021, following a four-year transition period.
This means that manufacturers must comply with the Regulation when placing new medical devices on the market from 26 May 2021.
The In-Vitro Diagnostic Devices Regulation (Regulation (EU) 2017/746) will apply from 26 May 2022, following a five-year transition period.
In the meantime, manufacturers can opt to place in-vitro diagnostic devices on the market under Directive 98/79/EC or under the new Regulation if they fully comply with it.
Question-and-answer guidance on the implementation of the new Regulations is available below.
Update: EMA updated the guidance with new and revised Q&As on the application of the Medical Devices Regulation in June 2021.
Questions and answers on implementation of the medical devices and in vitro diagnostic medical devices Regulations ((EU) 2017/745 and (EU) 2017/746) (PDF/280.05 KB) (updated)
First published: 28/02/2019
Last updated: 29/06/2021
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 (PDF/325.43 KB) (updated)
First published: 22/10/2019
Last updated: 29/06/2021
Some medicines are used 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.
Medical devices that are co-packaged or obtained separately must be CE marked in accordance with the medical device legislation.
Article 117 of the Medical Devices Regulation introduced a new requirement for medicines with an integral device.
From 26 May 2021, the marketing authorisation application should include a CE certificate 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. This requirement does not apply to Class I devices (non-sterile, non-measuring).
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 the medical device in relation to its use with the medicinal product.
On 3 June 2019, EMA published a draft 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 obligations in the Medical Devices Regulation, in particular the requirements under Article 117.
EMA is working to finalise the guideline as soon as possible in consultation with the European Commission.
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 and condoms coated with spermicides.
Role of EMA
Before it can issue a CE certificate, the notified body must seek a scientific opinion from the Agency 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 EMA e.g. in cases where the Agency 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 introduces a new classification system for companion diagnostics and the obligation to undergo a conformity assessment by a notified body.
Role of EMA
- 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.
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.
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 the Agency 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.