With less than a month to go, the clock is ticking for the next critical deadline, 26th September 2024, for legal manufacturers of legacy devices (class I up classified devices or those covered by existing directive certification) who wish to take full advantage of the extension provision covered in EU 2023/607. To continue placing your legacy device/s on the market until either 31 December 2027 (class III and IIb implantable1) or 31 December 2028 (remaining class IIb, IIa, Is and Im), certain criteria must be met:
- Continue to comply with Directive
- No significant changes
- No unacceptable risk
- Signed EU MDR Agreement by 26th Sep 2024
- Transfer appropriate surveillance to EU MDR Notified Body (if different from Directive Notified Body)
It is essential that you have
a) A signed EU MDR written agreement with an EU Notified Body (EUROPA – European Commission EU 2017/745 designated Notified Bodies)
Once your written agreement application has been made then preparations should continue with building your EU MDR 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 either 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 MDR (EU 2017/745) Article 10(9) 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.
