News about GMP/cGMP


EC: MDR, IVDR Manual on Borderline Devices

EC: MDR, IVDR Manual on Borderline Devices

The European Borderline and Classification Working Group (BCWG), a sub-group of the Medical Device Coordination Group, has created a manual for determining whether a product is classed as a medical device under the new regulations MDR and IVDR. BCWG developed the document as part of an attempt to prevent member states from having different interpretations of the legislation.

The manual highlights the view of BCWG regarding the qualification of products at the borderline of different categories, such as medical devices and in vitro diagnostics (IVDs), and rules for classifying medical devices and IVDs.
In the qualification sections, BCWG discusses the characteristics of borderline products and the outcome of assessing whether they are a medical device. For example, the manual cites nasal sprays with antibodies for COVID-19 as an intervention that exists at the borderline between medical devices and medicinal products. The product is not a medical device because of its mechanism of action.
The manual, the first version of which was published this month, is work in progress. Some sections still have to be completed.

Source: EU Roundup

EC: Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices