Commission issues guidance for Class I manufacturers

The European Commission has published a new guidance document for manufacturers of Class I devices under the medical devices Regulation (MDR, 2017/745), document reference MDCG 2019-15.

The 22-page document includes sections on:

• Definitions
• Placing on the market
• Integration of MDR in Quality Management System (QMS)
• Confirmation of product as a medical device
• Confirmation of product as a Class I medical device
• Procedures before placing on the market
• Compliance with general obligations for manufacturers
• EU Declaration of Conformity
• Affixation of CE marking
• Registration of devices and manufacturers in Eudamed
• Post Market Surveillance (PMS)

The guidance also provides an overview of the conformity procedures for the assessment of Class I devices, both with and without Notified Body (NB) involvement, drawing attention to the need for NB involvement for Class I devices which are sterile (Class IS), measuring (Class IM), or reusable surgical instruments (Class IR).