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© DEKRA CERTIFICATION B.V.
All relevant information regarding COVID-19 services in Europe
Several entities of DEKRA are certifying (medical) devices as a Notified Body. The certification process needs to be in compliance with the EU regulation for CE marking. At the recommendation of the EU Commission (2020/403) dated March 13, 2020, the market supervisory authorities have defined simplified processes for the market entry of medical devices and personal protective equipment (PPE). This accelerated process is designed to allow PPE and medical devices, which comply with the minimum basic requirements, to be approved for public use by the market supervisory authorities. The requirements for this accelerated process and minimum basic requirements are defined by the local governmental authorities. DEKRA entities in Germany and the Netherlands are able to test and review according the accelerated processes the equipment as defined by the local governmental authorities.
We would like to hereby inform you on whom to contact for each situation.
Personal protective equipment / protective masks (PPE)
DEKRA Testing & Certification GmbH in Essen, Germany, is one of two laboratories in Germany for testing PPE such as protective coronavirus masks, in accordance with new testing principles. For any queries for assessment of PPE please visit our German webpage.
Medical devices / respiratory equipment
DEKRA Certification B.V. in Arnhem the Netherlands is involved in the process for medical devices. At the moment we are involved in the accelerated and simplified assessment procedure to bring medical equipment on the EU market for use during the Coronacrisis. The authorities in the Netherlands (Ministry of Health Welfare and Sport and Health and Youth Care Inspectorate) are responsible for the market supervision. For any queries of assessment on medical devices please visit our Dutch webpage.
More information on cirismangement services of DEKRA click here.
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