Medical Device Regulation (EU) 2017/745 (MDR)

The Medical Device Regulation (MDR), Regulation (EU) 2017/745, sets the rules for placing medical devices for human use and their accessories on the market. It replaced Directives 93/42/EEC and 90/385/EEC and has applied since 26 May 2021. Its purpose is a high level of health protection for patients and users, through high standards of quality and safety for devices.

For CE marking of medical devices, apply to CE Danışmanı (CE Consultant); we manage the whole process for you.

Scope

The Regulation covers:

• All medical devices and their accessories, other than in vitro diagnostic devices
• Certain groups of products without an intended medical purpose that are listed in the Regulation
• Devices manufactured using non-viable tissues or cells of animal origin, or their derivatives
• Devices manufactured using derivatives of non-viable tissues or cells of human origin
• Clinical investigations of devices, so that the data are reliable and the safety of the subjects is protected

It does not cover:

• In vitro diagnostic medical devices, which have their own Regulation
• Medicinal products, including advanced therapy medicinal products
• Human blood, blood products, plasma and blood cells
• Cosmetic products; see the Cosmetic Products Regulation
• Transplants, tissues or cells of animal or human origin, apart from the non-viable derivatives mentioned above
• Products that contain or consist of viable biological material or viable organisms
• Food

Risk classes and who is involved

The notified body carries out its assessment at the manufacturer’s premises and on the technical documentation. Where one is involved, its identification number follows the CE marking.

Clinical evaluation

Every device, whatever its class, needs a clinical evaluation. The clinical evaluation report documents the clinical benefit and safety of the device, and it is kept up to date with data from both before and after the device is placed on the market.

What the manufacturer prepares

1. Classification of the device according to the rules of the Regulation
2. Risk management and demonstration of the general safety and performance requirements
3. Tests and analyses, where needed in accredited test centres
4. Clinical evaluation
5. Technical documentation; see technical file
6. Quality management system
7. Conformity assessment, with a notified body where the class requires it
8. EU Declaration of Conformity and CE marking

Standards commonly used

• EN ISO 13485: quality management systems for medical devices
• EN ISO 14971: application of risk management to medical devices
• EN ISO 10993: biological evaluation of medical devices
• EN ISO 14155: clinical investigation of medical devices for human subjects, good clinical practice
• EN ISO 11607: packaging for terminally sterilised medical devices
• EN ISO 17664: information to be provided by the manufacturer for the processing of devices

EU Declaration of Conformity

The manufacturer keeps the declaration up to date. It contains:

• Name, registered trade name or trade mark and address of the manufacturer and, where there is one, the authorised representative
• A statement that the declaration is issued under the sole responsibility of the manufacturer
• The Basic UDI-DI
• Product and trade name, product code, catalogue number or other reference that identifies the device, and its intended purpose
• The risk class of the device
• A statement that the device conforms to the Regulation and to any other applicable Union legislation that requires a declaration
• References to the common specifications used
• Where applicable, the name and identification number of the notified body, the procedure performed and the certificates issued
• Place and date of issue, name and function of the signatory, and signature

CE marking

The CE marking is affixed before the device is placed on the market, visibly, legibly and indelibly, to the device or its sterile packaging. Where that is not possible because of the nature of the device, it is affixed to the packaging. It also appears in the instructions for use and on any sales packaging.

Medical devices in Turkey

Turkey applies the Regulation through its own Medical Device Regulation, published in the Official Gazette of 2 June 2021 and aligned with (EU) 2017/745. The competent authority is the Turkish Medicines and Medical Devices Agency. The CE marking alone is not enough to sell in Turkey:

• The device is registered in the national Product Tracking System (ÜTS).
• The company selling the device needs a medical device sales centre authorisation, issued by the provincial health directorate.