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Updated: Aug 13, 2026

Implementation of Portable Emissions Measurement Systems (PEMS) for the Real-driving Emissions (RDE) Regulation in Europe
Published on: December 4, 2016
Annex II technical documentation assessed
A W van Drongelen1, B Roszek, E A E van Tienhoven
1Centre for Biological Medicines and Medical Technology, Dutch National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands. arjan.van.drongelen@rivm.nl
Abstract:
Annex II of the Medical Device Directive (MDD) is used frequently by manufacturers to obtain CE-marking. This procedure relies on a full quality assurance system and does not require an assessment of the individual medical device by a Notified Body. An investigation into the availability and the quality of technical documentation for Annex II devices revealed severe shortcomings, which are reported here.
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