CE marking is a certification mark that indicates conformity with health, safety, and environmental protection standards for products to the European Economic Area (EEA). The CE marking is also found on products sold outside the EEA that are manufactured in, or designed to be sold in, the EEA. This makes the CE marking recognizable worldwide even to people who are not familiar with the European Economic Area.
The CE marking is the manufacturer’s legally binding declaration that the product meets the requirements of the applicable EC directives. The mark consists of the CE logo and, if applicable, the four digit identification number of the Notified Body involved in the conformity assessment procedure.
The classification (I, IIa, IIb, III) and the conformity assessment procedure for a medical device are defined in Annex IX of Directive 93/42/EEC (MDD). Notified bodies carry out the prescribed inspections and issue the required certificates.
Due to the impact from CoViD-19 pandemic, the European Commission (EC) has adopted a proposal in Apr 2020 to postpone the date of application of the Medical Devices Regulation (MDR) by one year from 26 May 2020 to 26 May 2021.
This adoption has no impact on the date of application of the In Vitro Diagnostics Medical Devices Regulation, which becomes applicable from 26 May 2022.
DQS MED is a Notified Body (No. 0297) of the European Union and is authorized to perform conformity assessment according to EU directives that are mandatory to all medical device imported into the EU.
DQS MED carries out conformity assessment procedures subject to Annexes II, V and VI of the Medical Device Directive (MDD) and examine the technical documentation towards the requirements of Directive 93/42/EEC.
These Directives are being replaced by the new Medical Devices Regulation (MDR) and IVD Regulation (IVDR), published on May 5th 2017. Refer to here for more information.
DQS MED will provide CE marking service for MDR after the approval by the EU authority, which may be delayed due to the impact of CoViD-19 pandemic.