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New EU Regulation for Medical Devices

The New Regulation (EU) 2017/745 for medical devices (MDRs), which went into effect on May 26, 2021, is a major update to the regulatory framework in the European Union (EU). Manufacturers trust Siemens as the manufacturing solutions leader in MD&D which is why Siemens has summarized the new MDR requirements in this article with the aim to give MD&D companies the critical facts about the regulations, and provide support to medical device manufacturers on what they should be doing to ensure compliance.

What is addressed in the new requirements?

Medical Device and Diagnostic (MD&D) manufacturers must meet many obligations to operate in the EU concerning:

  • Lable changes and declaration of conformity
  • Certificates issued by a notified body

Download the article to learn more about the new MDR changes!

How are EU manufacturers preparing for compliance?

Manufacturers have a quality management system (QMS) in place where they can update product classifications and support clinical evaluation. They have adopted paperless manufacturing with the implementation of MES, which automates the generation of the electronic device history records (eDHRs) and electronic batch records (eBRs).

The best-in-class regulation-validated solution in the Medical Device Industry

Based on the new EU MDR regulations, Siemens Opcenter is a leading solution to handle the changes related to product labeling and documentation.

Find out how by downloading the article!