The new Regulation (EU) 2017/745, which will replace the current Directive 93/42/EEC on medical devices, introduces new, stricter requirements for placing devices on the market and distributing them within the EU.
But what about the new requirements regarding the quality management system (QMS)?
These requirements are detailed in Article 10.9 of the regulation: “Manufacturers must establish, document, implement, maintain, update, and continuously improve a quality management system that ensures compliance with the regulation and is proportionate to the class and type of device (excerpt from Article 10.9).”
The regulation introduces the concept of continuous improvement of the quality management system, whereas the EN ISO 13485 standard (which sets out the quality system requirements for the medical device industry) merely refers to maintaining the effectiveness of the Quality Management System (QMS).
The implementation of a quality management system now applies to all manufacturers, including Class I manufacturers (even though the QMS is not audited by a notified body for this class).
When implementing a QMS, the requirements of the regulation go further and take precedence over the requirements of the EN ISO 13485 standard.
New requirements to be incorporated into the QMS in the form of procedures:
– the implementation of the UDI system (Unique Device Identification system).
– The recording and reporting of data to the authorities via EUDAMED (the European database on medical devices).
Stricter requirements to be taken into account in the QMS:
– The clinical evaluation plan must be documented: protocol, conduct of clinical trials, etc.
– Vigilance (reporting of serious incidents or potential nonconformities) through a procedure that takes into account the severity of the incident, the implementation of corrective actions following an investigation, the submission of a report to the competent authorities, and the issuance of a safety notice to device users.
– Post-market surveillance (PMS) and post-market clinical follow-up (PMCF), as mentioned above in the standard, are key requirements of the regulation. The manufacturer must establish a PMS procedure formalizing the proactive collection of data on the device placed on the market in order to assess its use and, if necessary, implement preventive or corrective measures. The procedure will specify the preparation of periodic safety update reports (PSURs): a summary of the results and conclusions of the PMS data analysis submitted to the competent authorities. As appropriate, the manufacturer shall document the methods and procedures established to collect and evaluate clinical data on a device placed on the market (SCAC).
Isocèle Conseil can audit your quality system in accordance with the regulation’s requirements, identify areas for improvement, and assist you in bringing your QMS up to standard.
Please feel free to contact us!