MDR extension: accepted proposal to amend European Regulation 2017/745 (MDR)
The proposal to amend European Regulation 2017/745 MDR and European Regulation 2017/746 IVDR, announced on December 9 during the EPSCO meeting, has been approved.
The main objective of European Regulation 2017/745 MDR (Medical Device Regulation) is to “establish a robust, transparent, predictable and sustainable regulatory framework for medical devices, ensuring a high level of safety and health, while supporting innovation.“
The regulations significantly strengthen key elements of the previous regulatory framework set out in Council and European Parliament Directives 90/385/EEC and 93/42/EEC, such as: oversight of notified bodies, risk classification, conformity assessment procedures, and market surveillance and supervision.
Due to the impact of the Covid-19 pandemic, the implementation date of the European Regulation 2017/745 MDR was postponed by one year, to May 26, 2021, while May 26, 2024 was set as the end date of the transition period.
Despite progress, the overall capacity of notified bodies remains insufficient, in meeting all certification applications received, on time. In addition, many manufacturers are not sufficiently prepared in meeting MDR requirements by the end of the transition period.
This puts the availability of medical devices in the union market at risk.
In light of these reports, it has become necessary to extend the validity of certificates issued under the old directives and to extend the transition period. The extension is of sufficient duration to allow notified bodies sufficient time to perform the conformity assessments required of them.
Custom-made Class III implantable medical devices may be placed on the market until May 26, 2026 even in the absence of a certificate issued by a notified body for the conformity assessment procedure.
The necessary conditions for this to happen are:
- The submission of a formal application by the manufacturer/patron, by May 26, 2024, for the applicable conformity assessment;
- The signing of a written agreement between the authorized representative/manufacturer and the notified body (according to Section 4.3, second paragraph, of Annex VII), by September 26, 2024.
For both medical devices and in vitro diagnostics, the sell-off period, i.e., the end date for further making available devices/diagnostics already placed on the market before or during the end of the transition period, will be deleted. This would eliminate unnecessary disposal of safe devices/diagnostics already placed on the market.
Article 120(2) (MDR) has been amended as follows; devices may be placed on the market until the stipulated dates:
- December 31, 2027: for class III medical devices and class IIb implantable medical devices; except sutures, staples, dental fillings, orthodontic appliances, screws, wedges, plates, wires, pins, clips and connectors;
- December 31, 2028: Class IIb (other than those mentioned above), IIa and I devices.
The extension will be granted only if the following requirements are met:
- Medical devices that do not present unacceptable health and safety risks;
- Medical devices that have not undergone significant changes in design and/or intended use;
- Adaptation of the quality management system;
- Submission and/or acceptance of the manufacturer’s application for conformity assessment to a notified body before May 26, 2024.
This amendment to European Regulation 2017/745 will enter into force on the day of its publication in the Official Journal of the European Union.
This extension is not an opportunity to procrastinate the certifications according to European Regulation 2017/745 (MDR) and European Regulation 2017/746, but rather it is an auspicious opportunity to start the certification process immediately in order to manage the entire process with due priority for a “physiological” management of the company, thus avoiding constant emergency situations!!!
Gruppo FarmaImpresa receives first MDR certifications
This achievement is so significant because we are among the first companies in Italy to have received MDR certifications for some of our substance-based medical devices.
The achievement is the result of a long work we have been doing for two years to ensure the compliance of our medical devices in order to proactively respond to regulatory changes and promote the success of our customers.
The medical devices for which we received the first certifications under MDR Class IIb are water or oil emulsions containing simethicone, in 6 different versions.
