| Scope: |
This ESSENTIAL describes the regulatory requirements of medical devices in the European Union, based on the
- Regulation (EU) 2017/745 and its amendments
- MDCG (EU Medical Device Coordination Group) documents
Definition of "Medical Device" (Regulation (EU) 2017/745 - Article 2)
‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
- diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
- investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
- providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations,
Health products are classified into four risk classes, according to the risk associated with their use.
ANNEX VIII - CLASSIFICATION RULES, Chapter III, Rule 1 - 22.
Class I
Class IIa
Class IIb
Class III
For cybersecurity/software topics of medical devices, see: CRF EEA Cybersecurity, PCT "Medical Products".
Not in scope of this CRF:
- In-Vitro Diagnostics (see: ESSENTIAL EEA In-Vitro Diagnostics)
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| Legislation in force: |
REGULATION (EU) 2017/745 repeals the Council Directives
- 90/385/EEC (on the approximation of the laws of the Member States relating to active implantable medical devices) and
- 93/42/EEC (medical devices).
Scope of REGULATION (EU) 2017/745
MAKING AVAILABLE ON THE MARKET AND PUTTING INTO SERVICE OF DEVICES
- General obligations of manufacturers, authorised representatives, importers, distributors, Person responsible for regulatory compliance
- EU declaration of conformity, CE marking of conformity
- Medical devices nomenclature
- Unique Device Identification system (UDI system)
- Registration of economic operators and devices
- European databases and registration systems, e.g. EUDAMED
- Notified Bodies (requirements, subsidiaries and subcontracting, Designation and notification procedure, Monitoring and re-assessment of notified bodies, Challenge to the competence of notified bodies, Peer review and exchange of experience between authorities responsible for notified bodies)
- CLASSIFICATION AND CONFORMITY ASSESSMENT
- Classes I, IIa, IIb and III definition
- Conformity assessment procedures
- Clinical evaluation consultation procedure for certain devices
- CLINICAL EVALUATION AND CLINICAL INVESTIGATIONS
- POST-MARKET SURVEILLANCE, VIGILANCE AND MARKET SURVEILLANCE
- COOPERATION BETWEEN MEMBER STATES, MEDICAL DEVICE COORDINATION GROUP, EXPERT LABORATORIES, EXPERT PANELS AND DEVICE REGISTERS
- CONFIDENTIALITY, DATA PROTECTION, FUNDING AND PENALTIES
ANNEXES
I - General safety and performance requirements
II - Technical documentation
III - Technical documentation on post-market surveillance
IV - EU declaration of conformity
V- CE marking of conformity
VI - Information to be submitted upon the registration of devices and economic operators in accordance with Articles 29(4) and 31; core data elements to be provided to the UDI database together with the UDI-DI in accordance with Articles 28 and 29;and the UDI system
VII - Requirements to be met by notified bodies
VIII - Classification rules
IX - Conformity assessment based on a quality management system and assessment of the technical documentation
X - Conformity assessment based on type examination
XI - Conformity assessment based on product conformity verification
XII - Certificates issued by a notified body
XIII - Procedure for custom-made devices
XIV - Clinical evaluation and post-market clinical follow-up
XV - Clinical investigations
XVI - List of groups of products without an intended medical purpose referred to in Article 1(2)
XVII - Correlation table
Postponed the entry into force date of the complete Regulation (EU) 2017/745 to 26-MAY-2021.
Some regulations have been postponed to future dates:
Article 120 Transitional provisions (amended again by (EU) 2023/607)
Article 27 - Unique Device Identification system - was postponed to the following entry-into-force-dates:
With regard to reusable devices that are required to bear the UDI carrier on the device itself
(i) implantable devices and class III devices from 26-MAY-2023;
(ii) class IIa and class IIb devices from 26-MAY-2025;
(iii) class I devices from 26-MAY-2027;
Amendment of Article 120 - extended transitional period.
Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC from 25-MAY-2017 that were still valid on 26-MAY-2021 and that have not been withdrawn afterwards shall remain valid after the end of the period indicated on the certificate until the date set out in paragraph 3a of this Article applicable for the relevant risk class of the devices. Certificates issued by notified bodies in accordance with those Directives from 25-MAY-2017 that were still valid on 26-MAY-2021 and that have expired before 20-MAY-2023 shall be considered to be valid until the dates set out in paragraph 3a of this Article only if one of the following conditions is fulfilled (see original text)
Amendments to Regulation (EU) 2017/745 (Medical Devices) and 2017/746 (IVD products)
New Article 10a - Obligations in case of interruption or discontinuation of supply of certain devices
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| Comment on the comparability to EU legislation: |
not applicable... |