September 2022 saw the release of this much-anticipated document, it records the agreements reached by the Member State members of the Borderline and Classification Working Group (BCWG) following the exchanges under the Helsinki Procedure under Regulation (EU) 2017/745 on medical devices (the MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).
This manual has been drafted to help classify the borderline cases for which it is not clear from the outset whether a given product is a medical device, or an in vitro diagnostic medical device (IVD), or not.
Click Here for a copy of the Manual on Borderline and for the Background Notes, click here.
The Manual should also be read in conjunction with other documents providing guidance on borderline, such as:
- MDCG 2022-5 Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices
- MDCG 2019-11 Qualification and classification of software – Regulation (EU) 2017/745 and Regulation (EU) 2017/746.
And other documents providing guidance on classification, such as:
- MDCG 2021-24 Guidance on classification of medical devices
- MDCG 2020-16 Rev.1 Guidance on classification rules for in vitro diagnostic medical devices under Regulation (EU) 2017/746
If you need any help or assistance in classifying your medical device please contact us for further information at info@advena.mt.
