The initiative covers medical devices and software and was adopted to address the bottleneck that has arisen with Notified Bodies for MDR certification.
With the publication in the Official Journal of the European Union, the amendment to regulations 2017/745 and 746 for medical devices and in vitro diagnostic medical devices was approved which establishes the shift:
- as at 31 December 2027, for all class III devices and class IIb implantable devices, except suture materials, staples, dental filling materials, orthodontic appliances, dental crowns, screws, wedges, plates and prostheses, wires , nails, clips and connectors
- as at 31 December 2028, for class IIb devices other than those listed above, for class IIa devices and for class I devices placed on the market in sterile conditions or with a measuring function.
Devices for which the conformity assessment procedure pursuant to Directive 93/42/EEC did not require the intervention of a notified body, for which a declaration of conformity was drawn up before 26 May 2021 and for which the conformity assessment procedure under this Regulation requires the intervention of a notified body, may be placed on the market or put into service until 31 December 2028.
Devices that fall into the above categories may be placed on the market or put into service until the dates referred to in those paragraphs only if the following conditions are met:
- such devices continue to comply with Directive 90/385/EEC or Directive 93/42/EEC, as the case may be;
- there are no significant changes in design and intended use;
- the devices do not present an unacceptable risk to the health or safety of patients, users or other persons or to other aspects of public health protection;
- by 26 May 2024, the manufacturer has established a quality management system in accordance with Article 10(9) of the MDR;
- by 26 May 2024, the manufacturer or his authorized representative has submitted a formal application to a notified body for conformity assessment of a device certified with the previous legislation (MDD), or a device intended to replace such a device, and by 26 September 2024 the notified body and the manufacturer signed a contract.
The cases envisaged by the amendment to the regulation also include software as a medical device.
This is an important decision that gives time to manufacturers and prevents the exit from the market of a significant number of certified medical devices and software. It is also necessary to understand whether it will have an impact in specific tenders and contracts in which, precisely due to the original deadline (May 26, 2024), the MDR certification for clinical software was required for testing, under penalty of exclusion or termination of the contract.