The economic operators procedure (SYS-049), defines EU MDR requirements for communication with competent authorities, notified bodies, etc.
One of the biggest changes in the implementation of Regulation (EU) 2017/745 (MDR) is the requirement for the registration of economic operators in the new Eudamed Database. The economic operators are defined in Articles 10-15, and the Eudamed Database requirements are covered in Article 30. These economic operators include:
- EU Authorized Representative (Articles 11 & 12)
- Importers (Article 13)
- Distributors (Article 14)
- Person with Regulatory Responsibility (Article 15)
Each of the above economic operators must also comply with new roles and responsibilities that are defined in those articles. In order to facilitate the training and compliance with the European MDR, we created a new procedure for communication between economic operators. The new procedure is SYS-049. The procedure is a 9-page procedure with detailed requirements and cross-references to each applicable section of the MDR.
The economic operators procedure includes requirements for training and competency of the person that is assigned regulatory responsibility for your company. The procedure identifies the need to document roles and responsibilities in formal quality agreements with each economic operator (i.e., authorized representatives, distributors, and importers). The procedure also includes communication requirements with your Notified Body.
New EU MDR requirements include the requirements for additional of a label identifying the importer of your product(s). Each of the economic operators must also verify that technical documentation is being maintained, and certain operators must be able to provide that documentation to Competent Authorities if requested. The economic operators are required to register in the Eudamed database–similar to the FDA FURLS registration and listing database. Even the issue of liability insurance is addressed in the new EU MDR.
If your company needs additional training on the EU MDR, you might be interested in our 8-part training series. You might also consider purchase of the following procedures we updated specifically for compliance with the new EU MDR:
- SYS-010 Risk Management
- SYS-019 Post-Market Surveillance
- SYS-020 Recalls & Advisory Notices
- SYS-025 Technical Documentation
- SYS-030 Labeling & Translation
- SYS-036 Vigilance Reporting
- SYS-037 Implant Card Procedure
- SYS-039 UDI Requirements
- SYS-041 Clinical Evaluation Procedure
Please note: This product will be delivered to the email address provided in the shopping cart transaction. After the transaction is verified, please check your email for the download. To view all available procedures click here.
About the Author
Matthew Walker – QMS, Risk Management, Usability Testing, Cybersecurity
Matthew came to us with a regulatory background that focused on OSHA and NFPA regulations when he was a Firefighter/EMT. Since we kidnapped him from his other career, he now works in Medical Device Quality Systems and Regulatory Pathways. He is a Junior in George Washington University’s BSHS- Clinical Research Management Program, and we are proud to say that he is also a member of both the Golden Keys and Phi Theta Kappa Honor Societies! Matthew participates as a member of our audit team and has a passion for risk management and human factors engineering. Always the mad scientist, Matthew pairs his professional life in regulatory affairs with hobbies in the culinary arts as he also holds a Butchers/Meat Cutters certificate from Vermont Technical College.
Email: Matthew@FDAeCopy.com
Connect on Linkedin: http://www.linkedin.com/in/matthew-walker-214718101/