The recent EU commission publication (EU)2024/1860 aims to address the following:
- Accommodate the future roll-out of Eudamed modules – timeline for mandatory use of each module once available / verified as fully functional, rather than waiting until all modules are in place.
- Obligate informing competent authority of anticipated interruption or discontinuation of supply medical devices or in vitro diagnostic medical devices.
- Extend transitional provisions for some in vitro diagnostic medical devices if conditions are met.
Changes to IVD transitional provisions apply to existing products in the market (IVDD certified products). This includes legacy devices and products previously self-certified under IVDD, that now fall into classes D, C, B or A (sterile) under IVDR and are transitioning to IVDR. The new timeline does not apply to Class A products without sterile labelling and new products for which a declaration of conformity was not issued prior to May 26, 2022.
The proposal extends the validity of IVDD certificates effective as of 26 May 2022 but expired prior to the publication of the new regulation only if the manufacturer had applied for IVDR and signed a formal written agreement with a Notified Body prior to the expiry of the IVDD certificates or a derogation/exemption has been granted by a Competent Authority under either Article 54 or Article 92 of the IVDR.
To support the transition, manufacturers are required to meet these additional conditions as set out in the Regulation:
- Continue to comply with the Directive 98/79/EC
- No significant changes implemented in the design or intended purpose
- Do not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health.
- Put in place an IVDR compliant QMS no later than 26 May 2025
- Submit an IVDR application and has a signed formal written agreement with a Notified Body no later than applicable deadlines (dependant on class).
Class of IVD | IVDR Compliant QMS | Formal Application deadline | Formal written agreement with a Notified Body | Transition deadline |
IVDD certified devices* | 26 May 2025 | 26 May 2025 | 26 September 2025 | 31 December 2027 |
Class D** | ||||
Class C** | 26 May 2026 | 26 September 2026 | 31 December 2028 | |
Class B** | 26 May 2027 | 26 September 2027 | 31 December 2029 | |
Class A sterile** | ||||
Class A non- sterile | May 2022 (no change) | |||
New IVD products | ||||
*IVDD certificates from a Notified Body. **IVDD self-declared devices that did not need a Notified Body Certification.
It is essential that as a manufacturer you do not delay or divert from your application plans.
At Advena we have many years of experience helping clients in the medical device industry build robust and effective IVDR compliant Quality Management System and assist you in your NB registration. Once your application has been made, preparations should continue in building your IVDR compliant technical documentation. Advena can assist in conducting gap analyses, reviewing draft technical documentation and/or help you build your technical documentation, so it is ready for when called for review by your Notified Body.
If you have no quality management system (QMS) or perhaps only ISO 9001 certification, you will need to ensure you have a QMS that includes all the IVDR (EU 2017/746) Article 110 requirements.
If you have or intend to use a paper-based system or Windows based document storage system, have you considered moving to an electronic QMS (eQMS). Activ is a cost effective, easy-to-use option to manage your QMS, that frees up the time of the person responsible for your quality system.
Please review further information regarding Activ via our website https://advenamedical.com/activ-eqms-software/
Contact Us
For further information and personalised guidance, please feel free to reach out to Advena via either our website contact page, www.advenamedical.com, email (info@advena.com) or phone (01926 800153) to start a conversation today.
