2024 Label Guide: EU/CH Authorized Rep & UKRP - Casus …
2022年2月21日 · Medical device labeling requirements for the EU & Swiss Authorized Representatives and UK Responsible Person: where the info must appear & which symbols to use.
2020年2月25日 · this symbol is accompanied by an eIFU indicator. This indicator may represent the manufacturer’s eIFU website or any other appropriate indication on the use of eIFU. The indicator may be placed either alongside, beneath or surrounding the symbol
Symbols Glossary :: KORU Medical Systems (KRMD)
EC Representative. Indicates the authorized representative in the European Community / European Union. symbol 5.1.2 from ISO 15223‑1. Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements. Swiss Representative. Authorized Representative in Switzerland. ISO 20417 Reference no ...
ISO 15223-1: Medical symbols and labels - Regulatory knowledge …
2024年8月22日 · To avoid confusion with Ecuador (ISO 3166 ALPHA-2 country code EC), the symbol for the EU representative must be changed from EC to EU-REP. Even if Ecuador is not obligated to display the local representative on the label, counteracting this potential misleading effect is, of course, laudable.
98/79/EC, and EU Regulation 2017/745. Indicates the Authorized Representative in the European Community/ European Union. Indicates the date when the medical device was manufactured. Indicates the date after which the medical device is not to be used. Indicates the manufacturer’s batch code so that the batch or lot can be identified.
European Authorized Representative - Wikipedia
A European Authorised Representative (E.A.R.) serves as a legal entity designated by non European Union (EU) manufacturers, to represent them in the EU and ensure their compliance with the European Directives. The CE certificate and declaration of conformity can only be issued by a company located in the European Union.
European Union Authorised Representatives: A Complete Guide
2023年11月23日 · Article 4 and 5 of the Market Surveillance Regulation (EU) 2019/1020 requires that companies established outside the EU, but selling certain products to consumers in the single market, must have an authorised representative – in particular products that require CE marking.
European Authorized Representative for Clinical Trials - Emergo …
If your company does not have a physical location in Europe, you are required to appoint an Authorized Representative (also referred to as an EC REP or AR) to represent your company to European authorities.
EU Authorized Representative: Role of the EC Rep (2024) - Casus …
The MDR/IVDR uses the term “authorised representative”, the EU Harmonized Standard EN ISO 15223-1 uses the term “authorized representative in the European Community/European Union”, and an “EC REP” symbol is used to indicate the EU Authorized Representative.
Authorised representatives, importers and distributors under MDR
2022年5月16日 · The EC-REP symbol may be found on the label of a medical device, and it indicates who is the European authorised representative. Since the manufacturers outside the European Union need the authorised representative, they also need a defined importer.
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