Your product is on the market, now what?
After it has been launched on the market, manufacturers must be able to guarantee the performance and safety of their products over their entire product life cycle. In accordance with Annex XIII Part B, this is done as part of a follow-up surveillance, whereby the performance evaluation and the associated documents are proactively updated in a continuous process throughout the entire product life cycle.
Post-Market-Surveillance (PMS) therefore describes all the activities that manufacturers carry out in cooperation with other economic actors in order to establish a procedure for proactively setting up, collecting, reviewing, and keeping up to date experiences that they have with products placed on the market, made available on the market, or put into operation. Using this data, companies can identify any problems with their product, eliminate these problems at an early stage, and thereby continuously adapt their successive products to the needs of their users. The follow-up surveillance follows a defined monitoring plan (Article 56 Paragraph 6 IVDR).
Biomex GmbH would be happy to support you in the PMS process, for example with targeted literature searches on investigations into known risks relating to your product. You can also use our additional services for implementing the IVDR (Link). We are your 360° partner – contact us!