A method to evaluate technical files of Class I medical devices
Een methode voor de beoordeling van technische dossiers van Klasse I medische hulpmiddelen
26 May 2012, PDF |
34 pages |
van Drongelen AW, de Bruijn ACP, Geertsma RE, Wassenaar C
RIVM Report 318902010
In co-operation with the Dutch Inspectorate for Health Care, RIVM has developed a method for the enforcement of the Dutch Decree on medical devices under "Class I devices". This method was used for assessing the contents of technical files according to the requirements in the Decree. Manufacturers are legally bound to compile technical files as part of the conformity assessment procedure. The study included the development of a file evaluation form and a pilot study for examining 40 technical files. This method met the expectations, with minor adaptations being proposed. Of the 40 manufacturers, five withdrew their registrations leaving 35 files. Of these, 33 were received within 16 weeks and one later. None of these 34 files succeeded in meeting all the requirements. The number of shortcomings varied between 2 and 14. For 20 files, additional information for evaluating these files was requested. For 15 files, this information was received in time, allowing 29 files to be fully evaluated. The number of essential requirements that had been insufficiently addressed varied between 1 and 8 per file. All files had flaws in labelling and instructions for use. The results imply that most manufacturers participating in this study were familiar with the Decree. The quality of the technical files should be improved. This will stimulate a systematic evaluation of the safety and suitability aspects of devices to be put on the market.