Tests According to EU 2023/607 Directive
Directive EU 2023/607, published by the European Parliament and Council, amends the following two directives on transitional provisions for certain medical devices and in vitro diagnostic medical devices:
- EU directive 2017/745. This directive regulates the rules for the presentation of medical devices used for humans and accessories for such devices to consumers in the European Union countries. This directive also applies to clinical trials conducted on such medical devices and accessories.
- EU directive 2017/746. This directive regulates the rules for the presentation of in-vitro diagnostic medical devices used for humans and the accessories of these devices to consumers in the European Union countries. This directive also applies to performance studies carried out on such in-vitro diagnostic medical devices and accessories.
In short, these two directives are based on a high level of health protection for patients and users and establish a new regulatory framework in order to ensure the smooth functioning of the internal market for medical devices and in vitro diagnostics.
A few changes to EU directive 2017/745 are:
- Certificates issued by notified bodies in accordance with directives 90/385/EEC and 93/42/EEC, which are valid on 26 May 2021 and are not withdrawn thereafter, remain valid after the expiry date.
- Certificates issued by notified bodies in accordance with directives 90/385/EEC and 93/42/EEC and expire before 20 March 2023, remain valid under the following conditions:
- If, prior to the expiration date of the certificate, the manufacturer and a notified body have signed a written agreement for conformity assessment of the device covered by the expired certificate in respect of a device intended to replace or replace the expired certificate in accordance with the annexes to this directive.
- If the competent authority of a Member State has granted an exception to the applicable conformity assessment procedure under this directive or the manufacturer has been requested to carry out an applicable conformity assessment procedure.
- The devices specified in paragraphs 3a and 3b of article 3 may be placed on the market or put into service until the dates specified in this directive, with the exception of article XNUMX and provided that the conditions specified in paragraph XNUMXc of this article are met.
A few changes brought to the EU directive 2017/746 are:
- Devices placed on the market legally pursuant to Directive 26/2022/EC before 98 May 79 and devices legally placed on the market after 26 May 2022 may continue to be made available or placed on the market.
- With regard to devices referred to in articles 110(3) and (4) of this directive, directive 98/79/EC shall continue to apply to the extent necessary for the application of these paragraphs.
In general EU directive 2017/745 (MDR directive) provides three types of conformity assessment procedures:
- Conformity assessment based on quality management system and technical document assessment
- Conformity assessment based on type examination
- Conformity assessment based on product conformity verification
In advanced laboratories, tests are carried out for all three conformity assessments.
EU directive 2017/746 (IVDR directive) covers medical devices and accessories used in the testing of samples such as blood, urine, tissue supplied from the human body to detect infections, diagnose medical conditions, prevent disease or monitor drug treatments.
Among the numerous test, measurement, analysis and evaluation studies it provides for businesses in various sectors, our organization also provides testing services within the scope of EU 2023/607 directive with its trained and expert staff and advanced technological equipment.
