Medical device certification support
The new EU Regulation 745/2017 for Medical Devices (MDR) became effective on 5 May 2017, replacing two existing directives (93/42/EEC and 90/385/EEC). Its mandatory application starts on 26 May 2021. During this transition period, Instituto Pedro Nunes will support companies and institutions to implement the new medical device certification regulation.
HOW CAN IPN ASSIST YOU IN THIS TRANSITION?
Challenges to be addressed by medical device manufacturers with the introduction of the new Regulation:1. Content of the Technical Documentation:
- Develop a Quality Management System (QMS)
- Redefinition of Quality Management System (QMS) procedures
- Re-classification of medical devices
- Review of technical documentation
- Facilitating the UDI (Unique Device Identification) definition process
In accordance with Annexes II and III of the new Medical Device Regulation (MDR) the Technical Documentation must be completely revised. All Technical Documentation must be retained for at least 10 years, which in the case of implantable devices must be retained for at least 15 years.2. Post-Market Surveillance:
All manufacturers (regardless of the device classification) will have to assess market feedback on their product's performance, and the monitoring method must also be an essential part of the Quality Management System (QMS).3. Unique Device Identifier (UDI):
The UDI provides manufacturer and product identification, as well as, an assessment of the production methods. Is used to report corrective actions and serious events. The manufacturer is required to indicate the UDI on all products and at all product packaging layers.4. Classification:
With the implementation of the new Regulation a large number of medical devices will have their classifications changed - the number of classification rules has increased from 18 to 22. Therefore, all product classifications need to be re-examined by the manufacturer in accordance with Annex VIII.5. Quality Management System (QMS):
In the new Regulation the definitions of the QMS requirements are binding for all manufacturers regardless of their product classification. This amendment " forces " class I manufacturers to develop, implement and certify a Quality Management System (ISO 13485 and/or ISO 9001). In addition, other classes - which already have a QMS, will also have to review procedures to comply with the QMS requirements defined in the new Regulation.
email@example.com | 239 700 933