The Commission of the European Union (EU) has issued a detailed list of proposed codes to be used by EU Notified Bodies in the categorization and assessment of medical devices under the EU’s Medical Device Regulation (Regulation (EU) 2017/745, also known as the MDR) and the In Vitro Diagnostic Device Regulation (Regulation (EU) 2017/746, also known as the IVDR).
According to a draft Implementing Regulation issued by the Commission in late September, the list of codes and corresponding types of devices are necessary to “enable specifying the scope of the designation of conformity assessment bodies notified under (the Regulations).” The codes are intended to account for various device types as characterized by their design and purpose, manufacturing processes and technologies used, and will help to “ensure that conformity assessment bodies designated as notified bodies are fully competent for the devices they are required to assess.”
The proposed codes are contained in Annex I of the draft Implementing Regulation.
Read the text of the draft Implementing Regulation and Annex I.
Leave a Reply