(EU) Directive 2017/745 MDR Tests

Legislation numbered (EU) 2017/745 published in European Union countries amended the legal regulations numbered 2001/83/EC, (EC) 178/2002 and (EC) 1223/2009 and numbered 90/385/EEC and 93/42/EEC repealed the legislation.

The legal regulation (EU) 2017/745 regulates the rules for the presentation of medical devices for human use and accessories for such devices to consumers in the European Union. This regulation also applies to clinical studies conducted on such medical devices and accessories.

The scope of MDR has been expanded with this legal regulation to cover a number of products that do not have a medical purpose. This category includes some contact lenses, tattoo removal lasers, liposuction equipment, and the like. This legislative annex lists all relevant categories (Annex XVI). Reusable surgical instruments are generally included in the group as IR. Issues regarding their reusability are within the scope of notified body review from 2024. Other classification changes relate to software and nanomaterials.

A device, taking into account its intended use, must meet the general safety and performance requirements applicable to it and set forth in the appendix to this regulation. In accordance with this legal regulation, a device can only be offered to consumers under the following conditions:

• If duly supplied
• If properly installed and maintained
• If used in accordance with its intended use

Medical devices manufactured or traded in European Union countries must comply with the relevant legal regulations on safety and health. This also means that they comply with the legal regulations regarding the product and bear the CE mark. The medical devices directive (MDR) (EU) 2017/745 has been in effect since May 2021.

The Medical Devices Directive (MDR) 2017/745 (EU) replaces the previous Medical Devices Directive 93/42/EEC, and one of the key changes is the expansion of the definition of products and devices. Another important change is the establishment of a unique device identification system to collect and trace medical devices in a database.

Our organization also provides MDR testing services within the scope of the (EU) 2017/745 directive, with its trained and expert staff and advanced technological equipment, among the numerous test, measurement, analysis and evaluation studies it provides for businesses in various sectors.