Downloads
Downloads Certificates
Certificates for the quality management system and product certificates in accordance with Directive 93/42/EEC (MDD) and Regulation (EU) 2017/745 (MDR) as well as corresponding information letters on legacy devices
92/42/EEC (MDD)
Legacy devices
Regulation (EU) 2017/745 (MDR)
MDR Devices
EN ISO 13485
Quality management
Manufacturer declaration
Manufacturer’s declaration on Amendment 2023/607
Notified Body letter
Statement by the notified body on Amendment 2023/607
Q&A on 2023/607
Q&A paper of the EU Commission on the transitional arrangement of the MDD