Certification

Certified quality management system

We deliver finished medical devices as well as components to our distributors and OEM customers. Customer satisfaction and compliance with all applicable legal, normative and regulatory requirements are the focus of our quality management system. To meet this requirement, Möller Medical has established a comprehensive quality management system. We hold the following certificates:

• QM system according EN ISO 13485:2016
• QM system according to MDSAP (including the country-specific requirements of USA, Brazil, Canada and Australia)
• QM system according ISO 9001:2015
• MDR Certificate: Regulation (EU) 2017/745 according Annex IX Chapter I 
• MDD Certificate: Directive 93/42/EEC, Annex II and V

UPDATE April 2023: CE-marking of medical devices

For bringing medical devices onto the market in the European Economic Area, CE Declarations of Conformity and CE marking are required. The CE mark on the product indicates to users and regulatory authorities that the valid EU regulations are fulfilled.

We have been certified according to the Medical Device Regulation – MDR for short – since October 2021. The MDR-transfer is already completed for the majority of the Möller Medical medical devices. For these products, the CE-conformity assessment procedure is undertaken according to:

• Annex IX of the Regulation (EU) 2017/745

Due to a recently published Regulation ((EU) 2023/607) pertaining to MDR, the transition periods for 93/42/EEC have been extended. Therefore, the Directive Certificate acc. 93/42/EEC remains valid for some Medical Devices manufactured by Möller Medical GmbH. As the requirements of MDR Art. 120 3c are fulfilled, the certification for these products remains valid until 31st December 2028:

• Annex II of the EC-Directive 93/42/EEC
• Annex V of the EC-Directive 93/42/EEC

Should Declarations of Conformity acc. MDR ((EU) 2017/745) or Self-Declarations regarding validity of the Directive Certificate (93/42/EEC) be required, you can request these by mail: ra@moeller-medical.com. Please include the product name(s) and REF-Codes that you require declarations for.