Everybody must be able to rely on receiving safe care of good quality. When medical technology is involved, this is primarily the responsibility of the people who work in the care sector and of manufacturers of medical products.
The Health and Youth Care Inspectorate maintains supervision over the quality and safe use of medical products. The purpose of supervision is to make sure that a patient experiences the least possible or preferably no adverse effects of the use of medical technology (or research with medical technology). To achieve this goal we need to minimise the likelihood of incidents.
How supervision is arranged
In 2016, we focused our supervision on class I medical devices supplied to the Dutch market by manufacturers, authorised representatives and resellers. The organisation of supervision consists of four elements:
1. Risk analysis
In the first phase of risk indicators supervision, the Inspectorate makes an annual assessment of the risks that exist for the supply of safe medical devices. Each year the Inspectorate sends a questionnaire to new manufacturers who registered their class I medical devices. The Inspectorate further examines also whether vigilance-reports have been received from the manufacturer or about the medical device. On the strength of the gathered information and trends, the Inspectorate makes an assessment of the risks for each manufacturer – usually in comparison with other manufacturers with similar medical devices.
Based on the risk analysis, the Inspectorate produces a list of manufacturers that it will visit. The Inspectorate may visit a manufacturer unannounced or by appointment. The visit includes a conversation with the manufacturer and inspection of the technical file of the medical device.
The Inspectorate makes a report of each inspection visit and the manufacturer is given an opportunity to respond to factual inaccuracies.
After each visit, the Inspectorate looks at whether a manufacturer observe all relevant legislation (eg Medical Devices Act). If this is found not to be the case, the Inspectorate will impose an enforcement measure. The manufacturer may receive a warning and/or an administrative fine.