Post Market Surveillance and Vigilance
- The PMS process provides input for a number of other processes. Regular updating of all processes must be ensured.
- Prepare a Post Market Surveillance Plan (PMSP) for each product.
- New process for the Periodic Safety Update Report (PSUR) for Class IIa, IIb and III products
- New process for the Post Market Surveillance Report (PMSR) for Class I products
- Update the Incident and Field Safety Corrective Action (FSCA) reporting processes
Supply Chain
- Clean up your supply chain! Identify critical suppliers, distributors and importers.
- All Economic Operators play a key role in product and patient safety and must meet this commitment. This must be managed by written agreements (QAA-Quality Assurance Agreement).
- All foreign manufacturers must contract an Authorized Representative in the EU.
- The identification and traceability of products must be ensured throughout the supply chain. New processes for documentation, approval, registration and conclusion of written agreements.
New European database for medical devices EUDAMED
- New process for using and uploading EUDAMED information.
UDI (Unique Device Identifier) and labeling.
- New processes for storing and tracking UDI and importing UDI information into EUDAMED
- New labeling requirements
- Keep an up-to-date list of your UDIs
Regulatory compliance
- Document your compliance strategy. Define responsibilities and ensure that qualification requirements are met and documented.
Clinical evaluation and clinical study
- A clinical evaluation per product must be carried out. Unless there is sufficient justification that there is no need.
- If scientific literature is used, evidence of the relevance of the literature must be provided.
- A written report, either included in the technical documentation or referred to in the technical documentation, is required.
- PMCF is a continuous process for updating the clinical evaluation and should be part of the PMSP. The aim is to collect and evaluate clinical data.
- A clinical study must be conducted for all Class III devices and implants. Unless it is duly justified that it is sufficient to rely on existing clinical data.
- Clinical trials may also be required for lower-risk devices, depending on the availability of clinical data from other sources.
- New clinical trial provision: transparency. The sponsor must obtain information from EUDAMED.
Documentation requirements
- New provisions on storage and retention of technical documentation and other records.