EU Medical Devices Regulation: Regulation (EU) 2017/745 (Medical Devices Directive – MD Directive, MDD)

The European Union regulatory framework for medical devices since the 1990s, Directive 90/385/EEC (for active implants) and Directive 93/42/EEC (for other medical devices) have regulated medical devices that are placed on the European Union (EU) market. This legislation, which aims to ensure that medical devices are safe and perform as intended by the manufacturer, has been replaced by a new single EU Medical Device Regulation: Regulation (EU) 2017/745.

The system for ensuring that medical devices meet the necessary standards, specifications, quality, safety, and performance requirements is complex. This is reflected in the several years given to allow a smooth transition from the Directives to the Regulation.

EU Competent Authorities, Notified Bodies (i.e., conformity assessment bodies), manufacturers and other supply chain operators will need time to smoothly transition to the new EU Regulation. They therefore have a clearly defined transition period in the Regulation.

During the transition period, which lasted until 26 May 2020, medical devices could be placed on the EU market following either the current Directives or the new Regulation. Also, medical devices which were certified by a Notified Body under one of the old Directives may have (up to) an additional two or four years after 26 May 2020, during which they can continue to be placed on the market, i.e., up until 26 May 2022 or 26 May 2024 (depending on the type of certificate the Notified Body granted under the Directives). Class I devices that are not supervised by Notified Bodies under the Directives must comply with the new Regulation, from 26 May 2020 onwards, to be lawfully placed on the market.

It is therefore both anticipated and in line with EU legislation for medical devices to continue having, until at least 26 May 2024, regulatory documentation issued under the current Directives, including but not limited to:

  • Declarations of Conformity (DoCs),

  • Certificates issued by Notified Bodies,

  • Labelling (instructions for use, product labels, etc.), and others.

This documentation, issued under the Directives, can be valid until May 2024, as can any related Free Sale Certificates issued by EU Member States.

This valid documentation may therefore remain in circulation, in parallel with new regulatory documentation issued under the new Regulation. Regulatory documents, issued under the new Regulation, may have additional content and different formatting, compared to similar documents issued under the current Directives. This is, again, acceptable and in line with EU legislation.

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Scope of the Medical Device Regulation 2017/745:

The MDR applies to medical devices, accessories of medical devices and medical software.

Medical devices are broadly defined within the MDR as any instrument, apparatus or appliance, software, implant, reagent, material, or other item intended by the manufacturer to be used for humans for the purpose of diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of illness, injuries, or disabilities.

Accessories of medical devices refer to articles that despite not being medical devices, are specifically intended by the manufacturer to be used with a medical device.

We refer to software as medical device software (‘MDSW’) when it meets the definition of software (i.e. a set of instructions that processes input data and creates export data) and at the same time is intended for a medical application as stated in the definition of medical devices. Medical software can be used independently (SaMD: Software as a Medical Device) or drives and/or influences the use of a medical device.

Medical Device Regulation 2017/745 does not apply to:

  • In vitro diagnostic medical devices (see Regulation (EU) 2017/746);

  • Medicinal products (drugs) (see Directive 2001/83/EC);

  • Cosmetic products (see Regulation (EC) No 1223/2009);

  • Human blood and its derivatives;

  • Transplants, tissues or cells of human and animal origin;

  • Food (see Regulation (EC) No 178/2002).

CE Marking according to Medical Devices Regulation 2017/745 (cf. Article 20 of the MDD)European certification for medical devices

  1. Devices, other than custom-made or investigational devices, considered to be in conformity with the requirements of this Regulation shall bear the CE marking of conformity, as presented in Annex V. 2. The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.

  2. The CE marking shall be affixed visibly, legibly, and indelibly to the device or its sterile packaging. Where such affixing is not possible or not warranted on account of the nature of the device, the CE marking shall be affixed to the packaging. The CE marking shall also appear in any instructions for use and on any sales packaging.

  3. The CE marking shall be affixed before the device is placed on the market. It may be followed by a pictogram or any other mark indicating a special risk or use.

  4. Where applicable, the CE marking shall be followed by the identification number of the notified body responsible for the conformity assessment procedures set out in Article 52. The identification number shall also be indicated in any promotional material which mentions that a device fulfils the requirements for CE marking.

  5. Where devices are subject to other Union legislation which also provides for the affixing of the CE marking, the CE marking shall indicate that the devices also fulfil the requirements of that other legislation.

EU Authorised Representative

If a manufacturer is not a member of the European Community, he must appoint an authorised representative in the European Union to register a declaration of conformity or to obtain a CE mark of conformity to the Medical Device Directive.

In addition to providing a complete range of services with regards to certification and declaration of conformity of products according to the requirements of Regulation (EU) 2017/745 CCIS-EXPERTISE also provides an authorised representative in the European Union.

The EU declaration of conformity for Medical Devices shall contain all the following information (according to Annex IV):

  1. Name, registered trade name or registered trademark and, if already issued, SRN (a single registration number) of the manufacturer as referred to in Article 31; if applicable, its authorised representative, and the address of their registered place of business where they can be contacted, and their location be established;

  2. A statement that the EU declaration of conformity is issued under the sole responsibility of the manufacturer;

  3. The Basic UDI-DI (a unique numeric or alphanumeric code specific to a model of device and that is also used as the ‘access key’ to information stored in a UDI (Unique Device Identifier) database) as referred to in Part C of Annex VI;

  4. Product and trade name, product code, catalogue number or other distinct reference allowing identification and traceability of the device covered by the EU declaration of conformity, such as a photograph, where appropriate, as well as its intended purpose. Except for the product or trade name, the information allowing identification and traceability may be provided by the Basic UDI-DI referred to in point 3;

  5. Risk class of the device in accordance with the rules set out in Annex VIII;

  6. A statement that the device that is covered by the present declaration is in conformity with this Regulation and, if applicable, with any other relevant Union legislation that provides for the issuing of an EU declaration of conformity;

  7. References to any common specifications (CS) used and in relation to which conformity is declared;

  8. Where applicable, the name and identification number of the notified body, a description of the conformity assessment procedure performed and identification of the certificate or certificates issued;

  9. Where applicable, additional information;

  10. Place and date of issue of the declaration, name and function of the person who signed it as well as an indication for, and on behalf of whom, that person signed, signature.

Statutory reference

EU Directive 2017/745 on medical devices was published in the Official Journal of the European Union on 5 May 2017 and aims to provide a reliable, transparent, predictable, and sustainable regulatory framework for the medical device sector, ensuring a high level of public safety and health through innovative technologies. EU Directive 2017/745 entered into force on 25 May 2017 and fully replaced Directive 93/42/EEC as well as 90/385/EEC on implantable medical devices on 26 May 2021.

Full text of the EU Medical Devices Regulation 2017/745

CCIS-EXPERTISE specialists will help you to:

CCIS-EXPERTISE experts will advise you on all matters relating to the compliance of your products with the requirements of Medical Devices Regulation 2017/745 to optimise the time and cost involved, negotiate with notified laboratories, and ensure that your products are tested correctly.

We provide the following product certification services for the European market:

  • Consultation on the confirmation of compliance with Medical Devices Regulation 2017/745

  • Estimation of the cost of product analysis

  • Translation of technical documents

  • Evaluation of product compliance with Medical Devices Regulation 2017/745

  • Preparation and conducting of tests at a notified EU laboratory

  • Development of technical documentation

  • Declaration of Conformity preparation

  • Assignment of an authorized EU representative for your company

  • Full support during the certification process