Supervision of post-market surveillance
Post-market surveillance (PMS) is a collection of activities which the manufacturer has to carry out in order to monitor the safety and performance of its product once it has been launched onto the market. The aim is for the manufacturer always to have up-to-date information to provide a basis for improving the product or its safe usage wherever necessary.
It is essential that manufacturers carry out PMS in order to guarantee the quality and safety of medical devices. The Health and Youth Care Inspectorate (HYCI) assesses the extent to which manufacturers carry out PMS and whether that is compliant with the applicable legislation.
Post- market surveillance is also an important topic in Europe. The new European Medical Device Regulation (MDR), which will come into effect in 2021, contains a more detailed description of the manufacturer's obligation to carry out PMS.
During a conference on 4 July 2016, the inspectorate informed a large number of Dutch manufacturers and umbrella organisations about how PMS should be implemented and the way in which we are going to supervise this. You can read the report and the presentations here. (Dutch)
Findings of PMS inspections
At the aforementioned conference it was announced that we would carry out ten PMS inspections at Dutch manufacturers of medical devices. The aim of these inspections was to draw more attention to the requirements of the new MDR and to encourage its implementation. The manufacturers to be inspected were selected from various product categories, produce class IIa, IIb or III medical devices and have more than ten employees according to the Chamber of Commerce. The inspections took place in 2016 and at the beginning of 2017.
The findings are available in this factsheet (Dutch).
See also a more detailed interpretation of our vision of post-market surveillance (Dutch).
Previous investigation into implementation of PMS by RIVM and HYCI
In 2009 RIVM investigated the quality of PMS and this revealed that the information obtained rarely leads to an improvement in the process. Although product improvement and PMS should be inextricably linked, in practice they appear to be two separate processes. The 'quality cycle' described by RIVM is rarely completed.
In a number of recent investigations the Inspectorate has also been able to establish that the manufacturers investigated often have only a very limited (PMS) system. This was the conclusion with regard to the reports (Dutch) on:
The manufacturers' responsibility
The European directive 93/42/EEC describes how a manufacturer is responsible for monitoring the performance of the product it supplies. The manufacturer must check whether the performance of the product fulfils the set requirements as regards quality and safety, in other words whether the product does what it has been made for and can be safely used.
The experiences of care professionals and/or patients with using the product can provide a basis for further investigation by the manufacturer. This may mean that the manufacturer then needs to take necessary corrective or preventive measures.