Product surveillance (Post Market Surveillance, PMS) involves the collection and evaluation of information on the properties of medical devices during their use (safety, quality, durability, performance), the implementation of required corrective actions for the device and, if necessary, the planning and implementation of safety measures in the market. All importers of medical devices (e.g. manufacturers, importers, wholesalers, retailers) are obliged to participate in product surveillance and maintain a functioning product observation system.
PMS information is derived from the following sources in particular:
- The occurrence of incidents on the market (Materiovigilance).
- Customer complaints, e.g. including those from sales personnel.
- Information obtained during maintenance and repair operations.
- The periodic review and assessment of the literature in the relevant specialist area (particularly scientific publications about the specific device, competitor devices, the relevant state of the art in medicine and technology, standards).
- Systematic customer surveys.
- Systematic studies (Post Market Clinical Follow-up, PMCF).
a) Tasks of the first placer on the market (manufacturer, its EU authorized representative, importer),
The first placer on the market is obliged to maintain a functioning PMS system designed to ensure that all relevant PMS information is collected and evaluated, the technical documentation (incl. clinical evaluation report) is periodically updated with data from product surveillance, any investigations and corrective actions are initiated and, if necessary, safety measures are implemented in the market (e.g. recalls, technical updates, warnings to customers). The first placer on the market must report any incidents from Switzerland and safety measures within the time limits to Swissmedic (Materiovigilance and Field Safety Corrective Actions, FSCA). The Materiovigilance System should prevent any recurrence of incidents. The first placer on the market is responsible for investigating the causes of any event and for implementing any safety measures. These operations are monitored by Swissmedic. In the event of problems with medical devices, it is important for the company concerned to be able to translate the information received into safety measures and to operate an effective system for the recall of products and for other safety measures, incl. the traceability of devices in the market. Traceability must be ensured at least down to its own customers. Depending on the risk potential in the individual case, traceability down to the individual patient may also be required. Swissmedic recommends that importers conclude contracts with suppliers and/or manufacturers in order to arrange access to the excerpts from the technical documentation and to define the responsibilities concerning the product surveillance system (Section 5 MepV: Product surveillance, Reporting of incidents and safety measures which are required by the authorities.
b) Tasks of further placers on the market
Other placers on the market include trade intermediaries, pharmacies and other points of dispensation.
They are obliged
- to collect complaints and relevant experience on the use and efficacy of medical devices and send these to the first placer on the market,
- to carry out recalls and other safety measures directly or to forward corresponding information to the individuals concerned (e.g. professional users, patients).
Swissmedic recommends that further placers on the market define and document a process to ensure that complaints and relevant experience are forwarded without any delay to the responsible distributor, importer or manufacturer and recommends to regulate these responsibilities contractually. This avoids any lack of clarity in the communication and collection of information and in the implementation of safety measures.