The obligations of manufacturers once the device is on the market are summarised in the following sections;
Maintain the risk management system described in Annex I section 3 (Article 10, 2.),
Execute the planned Post Market Clinical Follow-up activities as described in Annex XIV Part B (Article 10, 3.),
Keep up to date the Technical Documentation described in Annexes II and III (Article 10, 4.),
Manufacturers of custom made devices must also keep up to date the documentation described in Annex XIII section 2 Article 10, 5.),
Keep the technical documentation, including records of any changes in the documentation or certificates, available for the EU authorities for at least 10 or 15 years after the final placing of the device variant on the market. This includes keeping up to date any technical documentation retained by Authorised Representatives (Article 10, 8.),
Keep up to date and continually improve the quality management system; (a) to ensure the manufactured product remains compliant, including with any changes in the harmonised standards, and (b) that the numerous procedures and systems required by the regulation (listed a. to m.) remain effective and compliant (Article 10, 9.),
Maintain the Post Market Surveillance system activities as described in Article 83, paying particular attention to the interfaces listed in paragraph 3 a-h (Article 10, 10.),
Immediately take corrective action for any nonconforming devices, informing any Distributors, the Authorised Representative and Importer. Immediately Inform the Competent Authorities and the Notified Body of any devices which pose a serious risk (Article 10, 12.),
Report any serious incidents to the authorities, at the latest within 15 days after becoming aware, report any field safety corrective actions, ideally in advance of taking action, as well as changes in trends in other incidents, all as described in Articles 87 and 88 (Article 10, 13.),
Maintain traceability records of any devices receive from or supplied to any other economic operators (e.g. importers or distributors) or supplied to any health institutions of health care professionals (Article 25, 2.),
Update the EUDAMED database within one week of any changes to the registration data and re-confirm the accuracy of the data registration every second year (Article 31, 4 and 5.).
Deliverables for demonstrating compliance:
(1) Evidence of the benefit-risk determination being reviewed,
(2) Evidence of the Post Market Clinical Follow-up activities being performed and the Clinical Evaluation being updated,
(3) Up to date technical documentation, including the Authorised Representative’s copy, and history of changes,
(4) Evidence that the quality management system covers all the required processes and is being reviewed and updated,
(5) Evidence of the Post Market Surveillance activities taking place with the required scope,
(6) Evidence of deviations and complaints being investigated and corrective action being taken to address nonconformities with appropriate parties being informed,
(7) Evidence of incidents being investigated and serious incidents being reported within the required time,
(8) Evidence of the person responsible for regulatory compliance carrying out their duties (Article 15),
(9) Evidence of traceability of supply,
(10) Evidence of updating or confirming the registration data.
Guidance
until replaced MEDDEV 2.12-1 rev. 8 remains effective together with the additional guidance published in 2019;
- Manufacturer incident report (MIR) version 2020.
- Field safety corrective action (FSCA).
- Field Safety Notice (FSN) template.
- FSN customer reply.
- FSN distributor/importer reply.
- Trend report.
- Periodic summary report.
Article 83.4 says: “If, in the course of the post-market surveillance, a need for preventive or corrective action or both is identified, the manufacturer shall implement the appropriate measures and inform the competent authorities concerned and, where applicable, the notified body.”
Shall all CAPA’s relating to PMS be sent to the CA and NB? So for example a CAPA was initiated based on PMS data showing an event that was systemic but not necessarily of high risk or related to safety or a non-conformance to the regulations.
Keep in mind, according to Article 83.1, that the PMS system should be proportionate to the risk class and appropriate for the type of device. Also it should be an integral part of the manufacturer’s quality management system. While each manufacturer must decide his own procedures, it follows that the criteria for reporting should be described in a quality system procedure; not only those reports made according to Article 87, but also the reporting of preventive and corrective actions according to Articles 85 or 86.