In 2020, the European Union institutions have adopted a Regulation 2019/1020/EU that intends to strengthen market surveillance in the European Union. The Regulation prohibits sales from outside the European Union directly to end-users in the EU Member States. Such sales are only allowed if the exporter has a subsidiary office in the EU, works through importers, has an authorized representative or ‘responsible person for CE-marked products’, or uses a fulfilment service provider. The Regulation came into force from July 16, 2021. After this date, CE marked products will not be sold in Europe without an EU Fulfilment Service Provider
The Fulfilment Service Provider is a natural or legal person resident in the EU, that is appointed to communicate with the market surveillance authorities of the EU Member States in which CE-marked products are sold. This person is not a sales representative or distributor. S/he will also not take over your product liability. The Responsible Person’s role is primarily to be a single point of contact for the authorities, and to communicate on your behalf about questions related to regulatory conformity and CE compliance. For that reason, you are best served with a person that is an expert on CE marking and the CE marking regulations, standards, and approval procedures.
Duties of
EU Responsible Person
are defined in Guidelines for economic operators and market surveillance authorities on the practical implementation of Article 4 of Regulation (EU) 2019/1020 on market surveillance and compliance of products:
Consulting Agency "AFINA"
European Regulatory Compliance Services
Kaprova 42/14
Prague 110 00
+420 608 049 029
Czechia
AFINA s.r.o. © 2023