PPE for the protection against Covid-19
VTC offers appropriate services when marketing, importing and/or distributing personal protective equipment against the Corona virus. A fast and efficient procedure is of great importance to get good and safe products to the care personnel. VTC has 25 years of experience in the field of testing and certification of ppe and is very well informed about the applicable laws and regulations and technical requirements.
The marketing, import and distribution of these products are subject to the requirements of the PPE Regulation. In addition, the European Commission has asked the approving authority to speed up the approval procedure by means of a recommendation. It is also possible to use standards other than the European standards. However, there are conditions attached to this. There is also the possibility to have ppe that offer protection against SARS-CoV-2 authorised on the basis of a modified EN 149 standard. It is the Notified Bodies who ultimately have the authority to issue the approval. Voluntary certificates or certificates from institutes that do not have the correct notification are still not valid!
Another problem in this market is the lack of testing capacity. Many products are therefore offered with refutable test reports. In this exceptional situation, should we be satisfied with products that clearly do not meet the requirements or not? Do we have to break the law? We don't think so. There are plenty of opportunities to test products if necessary and then allow them into the internal market. Products may even be placed on the market without the conformity procedure having been completed. Of course, under certain conditions.
Importers and distributors are also bound by the law. It is precisely the flash trade in which a random 'certificate' is hung on a random product that has become practice. We therefore advise market participants to contact us and discuss the working method to be followed and the necessary documentation.
- Assessment of certification documents for suitability for use in the import and distribution of PPE and medical devices against Covid-19 contamination.
- Advice in the procurement of ppe and medical devices.
- Advice with the import of ppe and medical devices.
- Testing of filtering face masks and surgical masks for EN 149, PPE-R/02.075 or EN 14683.
- EU type approval certification of ppe against Covid-19 contamination.