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Commission issues guidance for Class I manufacturers

  • Posted by: inetika
  • Category: GLOBAL NEWS

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).