Hi,
I am a distributor of a legacy medical device originally placed on the EU market under MDD, with a declared shelf life of 2 years. The original equipment manufacturer (OEM) has recently extended the shelf life of this device to 3 years. I would like to understand what documentation or regulatory steps are required to continue placing this product on the Greek market with the updated shelf life.
Specifically, I would appreciate guidance on the following:
References already consulted:
Thank you in advance for your insights.
I am a distributor of a legacy medical device originally placed on the EU market under MDD, with a declared shelf life of 2 years. The original equipment manufacturer (OEM) has recently extended the shelf life of this device to 3 years. I would like to understand what documentation or regulatory steps are required to continue placing this product on the Greek market with the updated shelf life.
Specifically, I would appreciate guidance on the following:
- Do I need to notify the Greek competent authority regarding this change?
- Any applicability of 28 days clause (16(4))
- What documents must be in place to support the extended shelf life claim (e.g., stability studies for evidence, DoC, OEM confirmation)?
- Does this change qualify as a relabelling activity under Article 16 of MDR-2017/745, if have to only re-label the packaging?
References already consulted:
- MDCG 2021-26: Q&A on repackaging & relabelling under Article 16 of Regulations (EU) 2017/745 and 2017/746
- MDCG 2021-25 Rev.1: Application of MDR to legacy devices and those placed prior to 26 May 2021
- Guidance for notified bodies, distributors, and importers under Article 16(4) of MDR
- Consolidated version of Regulation (EU) 2017/745
- Johner institute blog on Distributor requirements
Thank you in advance for your insights.
