MDCG 2022 15
MDCG published a guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according to the IVDD.
This guidance document outlines the activities to be performed by notified bodies as part of the appropriate surveillance defined in Article 110(3) last subparagraph IVDR. To clarify elements to be verified by notified bodies, this guidance document also covers requirements concerning certain manufacturers’ obligations, especially in respect of their quality management system.
While, major part of the guidance was issued for the notified bodies, Manufacturers need to focus on the Quality Management systems listed in the document.
Section 3 of the guidance states the - Requirements in respect to the manufacturer’s quality management system and related obligations
Article 110(3) IVDR lays down that devices may be placed on the market or put into service until 26 May 2025 when they are covered by valid certificates under the IVDD, provided that they continue to comply with the IVDD and that there are no significant changes in the design and intended purpose. Therefore, in principle, the quality management system approved under the Directive needs to be maintained.
In addition, in accordance with the fourth subparagraph of Article 110(3) IVDR, all relevant requirements set out in Chapter VII IVDR on post-market surveillance, market surveillance, vigilance and registration of economic operators and of devices apply to ‘legacy devices’ in place of the corresponding requirements in the Directive. IVDR requirements will be subject to the notified body’s surveillance activities as described in section 4.
Until the European database on medical devices (EUDAMED) is fully functional, manufacturers or their authorised representatives are expected to apply the respective national provisions and to take into account MDCG 2022-12.
IVDR requirements that are not related to post-market surveillance, market surveillance, vigilance, registration of economic operators and devices should in principle not apply to economic operators in respect to ‘legacy devices’. Examples for provisions not applicable in respect to ‘legacy devices’ are Article 15, Article 16(3) and (4), Article 22, Article 24, Article 29. This is without prejudice to the possibility for economic operators to follow any other IVDR requirements also for ‘legacy devices’, especially if they deal with both ‘legacy devices’ and IVDR devices and want to apply the same procedures for all devices.
Section 4 of the guidance addresses - Surveillance according to Article 110(3) IVDR
Where 4.3 talks about - Review of Quality Management System documentation
For manufacturers making use of Article 110(3) IVDR the notified body needs to verify the following:
¾ If the scope of devices covered by the IVDD certificate(s) remains or if and which devices are discontinued. To that end, it is important for the notified body to consider the manufacturer’s transition plan for IVDR compliance.
- If the manufacturer has adjusted its quality management system according to the requirements of Article 110(3) IVDR concerning significant changes, taking into account the content of MDCG 2022-6 (“change regime”).
- If the manufacturer has made the necessary adjustments to the quality management system on post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices. This can be done by verifying that the manufacturer has changed the procedures for post-market surveillance etc. (see section 3) in line with the IVDR or has changed its quality management system completely to adapt to IVDR requirements, which cover also those in the Directive.
- If all appropriate processes relating to post-market surveillance, including risk management and performance data, feed into the post-market surveillance plan.
Apart from that Manufacturers need to
- make available PMS plans and any PMS reports to their notified bodies in the framework of surveillance audits in order to allow the notified body to verify that the quality management system has been appropriately adapted and remains compliant for the certificate(s) issued under the IVDD.
This document also lists down some complex instruction for the notified bodies where they are advised to treat different manufacturers scenario’s differently.
As a manufacturer, it is important to ensure that the quality management systems are in place and in accordance to the regulatory requirement. With different transitional dates, your products might require different strategies and quality management systems.
This is the right time to get all the procedures in place and make your medical devices compliant. A non-complaint device can be taken off the shelf or receive penalties.
Do not wait until the deadlines!
Protect your medical devices with right regulatory strategies by contacting our experts.
Drop us an email at email@example.com and we will be here to be your regulatory risk partners for medical devices, diagnostics and digital health!
Read the complete guidance by clicking here