UPDATE: MDCG 2020-16 rev.4 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746
The guidance document MDCG 2020-16 has been recently updated. To offer some background to this guidance document, originally published in 2020, this guidance document provides clarification on the classification of in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2017/746 (IVDR), focusing on Annex VIII classification rules. It applies to diagnostic services performed on EU ...
Classification Rationales
In the rapidly evolving European regulatory landscape, correct classification of medical devices and in vitro diagnostic medical devices (IVDs) under the Medical Device Regulation (MDR, EU 2017/745) and In Vitro Diagnostic Regulation (IVDR, EU 2017/746) is pivotal. Misclassification can lead to delays in market access, costly rework, compliance risks, and, most importantly, patient safety issues. ...
