Back in 2019, the Medical Device Coordination Group (MDCG) published guidance MDCG 2019-6, a Q&A document related to requirements around notified bodies. The Commission has now issued revision 3 of the paper. An insightful aspect has been added under section I.6. This part addresses to what extent notified bodes may provide pre-certification services.
The guidance clarifies that pre-certification services (e.g. review of clinical data or assessment of the quality management system) are not allowed unless an application is lodged by the manufacturer.
The notified body may still provide trainings outside conformity assessment activities. But these should not be client-specific and not intended by only one manufacturer/ relevant supplier and they should also not be conducted at the manufacturer’s or supplier’s premises.
Additional details are included in the paper. Please let us know should you wish us to send you a copy. You may also visit our library section for additional relevant documents.
Source: European Commission