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European Medicines Agency (EMA) Guidance
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Human regulatory: overview
Medical devices
Medical devices are products or equipment intended for a medical purpose. They are regulated at EU Member State level, but the European Medicines Agency (EMA) is involved in a number of regulatory processes.
Human
Medical devices
Regulatory and procedural guidance
Page contents
In this section
EMA regulatory responsibilities
Medical device shortages during public health emergencies
Medical device legislation
Page update history
Related content
External links
Related EU legislation
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. It can also include a review of technical documentation from the manufacturer on the safety and performance of the device - this depends on the type of device.
EU Member States designate accredited notified bodies to conduct conformity assessments.
Many medicines need a medical device to be used. With ongoing advances in technology, the number of new therapies that combine medicines and devices is increasing.
For certain high-risk devices, notified bodies need to consult expert panels before issuing a CE (Conformité Européenne) certificate. These expert panels benefit from EMA's technical and scientific support.
Initiatives are ongoing to extend the role of expert panels to support the development and assessment of breakthrough and orphan medical devices.
In some cases, the notified body must seek a scientific opinion from EMA or a national competent authority before issuing a CE certificate.
In this section
Medicinal products used in combination with a medical device
Marketing authorisation dossier requirements for a medicine when it is used with a medical device and conformity assessment requirements for the device component
High-risk medical devices
Guidance on the consultation procedures and scientific advice for high-risk medical devices and the outcomes of the procedures
Medical devices with an ancillary medicinal substance
Guidance on the consultation procedure for ancillary substances in medical devices and the outcomes of the procedure
Companion diagnostics ('in vitro diagnostics')
Guidance for notified bodies on obtaining a scientific opinion from EMA regarding the suitability of companion diagnostics for medicinal products
Borderline products
EMA’s role regarding borderline products with unclear regulatory status
Medical devices made of substances that are systemically absorbed
EMA's role in the regulatory process for medical devices made of substances that are systemically absorbed
Orphan medical devices
Manufacturers of high-risk medical devices and notified bodies can request advice on possible orphan device status and on the clinical evaluation of orphan medical devices
Breakthrough medical devices (BtX)
EMA is set to launch a pilot programme in the second quarter of 2026 that will allow manufacturers of breakthrough devices to access enhanced regulatory support and priority scientific advice from the medical device expert panels
Medical device expert panels
The expert panel's responsibilities, composition and information on how to join
Combination Products Operational Group (COMBO)
Information about the group's mandate, composition, agenda and minutes
EMA regulatory responsibilities
EMA's regulatory responsibilities vary by device category, including in vitro diagnostics. An overview is available below.
EMA can only address questions that fall within its remit.
Medicines used in combination with a medical device
EMA assesses safety and effectiveness of medicines used in combination with medical device within centralised procedure application for medicinal product
Medical devices with an ancillary medicinal substance
Notified body must seek EMA scientific opinion on quality, safety, and usefulness of ancillary medicinal substance if ancillary substance:
Is derived from human blood or plasma
Has been previously evaluated by EMA
Falls in mandatory scope of centralised procedure
Companion diagnostics
Notified body must seek EMA scientific opinion on suitability of companion diagnostic to medicinal product if the latter falls in scope of centralised procedure
Medical devices made of substances that are systemically absorbed
Notified body must seek scientific opinion of a competent authority - EMA provides scientific opinion on compliance of substance with requirements in Annex I of Directive 2001/83/EC
High-risk medical devices
EMA supports medical device expert panels that provide opinions and views to notified bodies on scientific assessment of certain high-risk medical devices and in vitro diagnostics
Orphan medical devices
EMA supports medical device expert panels that provide advice to notified bodies and manufacturers of high-risk medical devices on a possible orphan device status and on the clinical evaluation of orphan medical devices
Breakthrough medical devices
EMA is set to launch a pilot programme in the second quarter of 2026 to implement guidance on breakthrough devices (BtX). Under this pilot, manufacturers of breakthrough devices will be able to access enhanced regulatory support and priority scientific advice from the medical device expert panels administered by EMA.
Medical device shortages during public health emergencies
In the context of a public health emergency, the Executive Steering Group on Shortages of Medical Devices (MDSSG) ensures coordination and a robust response to medical device supply issues within the EU.
The MDSSG establishes a list of critical medical devices that need to be monitored during the public health emergency and enables swift and coordinated measures to identify, prevent or mitigate potential or actual shortages.
The MDSSG is supported by the Medical Device Shortages Single Points of Contact Working Party (MD-SPOC WP). The working party is composed of single points of contact (SPOCs) for medical device shortages in the national competent authorities responsible for medical devices.
For more information, see:
Executive Steering Group on Shortages of Medical Devices
Medical Device Shortages Single Point of Contact (SPOC) Working Party
Medical device 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. They introduced new responsibilities for EMA and national competent authorities in the assessment of certain categories of medical device, as follows:
Medical Devices Regulation - applies for manufacturers placing new medical devices on the market; applies since 26 May 2021, repealing Directive 93/42/EEC on medical devices and the Directive 90/385/EEC on active implantable medical devices
In Vitro Diagnostic Devices Regulation - applies since 26 May 2022, repealing 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:
Questions and answers on implementation of the medical devices and in vitro diagnostic medical devices Regulations ((EU) 2017/745 and (EU) 2017/746)
Reference Number:
EMA/37991/2019 Rev.6
English (EN) (472.98 KB - PDF)
First published: 28/02/2019
Last updated: 02/12/2025
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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
Reference Number:
EMA/37991/2019 Rev.6
English (EN) (616.75 KB - PDF)
First published: 22/10/2019
Last updated: 02/12/2025
View
Page update history
An update log is available to show the date and summary of changes to this webpage. It does not include updates to linked documents or minor edits like typos or broken link fixes.
The tracking of updates begins in March 2026.
See update history
Related content
Crisis preparedness and management
Authorisation of medicines
Procedural timetables
Supporting innovation
External links
Medical Device Coordination Group Working Groups
European Commission: Notified bodies
Related EU legislation
Medical Device Regulation (EU) 2017/745
In Vitro Diagnostic Medical Device Regulation (EU) 2017/746
Regulation on EMA's Reinforced Role (Regulation (EU) 2022/123)
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