EC-REPサービス

EC-REP（European Authorized Representative）とは、欧州連合（EU）内での非欧州メーカーの法的代理人として任命される機関です。

The terms EC-REP, CH-REP, and UK-RP refer to different types of authorized representatives required for medical devices and in vitro diagnostic devices (IVDs) in the European Union (EU), Switzerland, and the United Kingdom (UK), respectively. Each of these representatives plays a crucial role in ensuring that manufacturers comply with the regulatory requirements of their respective markets.

1. EC-REP (European Authorized Representative)
   An EC-REP, or European Authorized Representative, is a legal entity established within the European Union that acts on behalf of a non-EU manufacturer to ensure that their medical devices and IVDs comply with EU regulations.
2. CH-REP (Swiss Authorized Representative)
   A CH-REP, or Swiss Authorized Representative, is a legal entity established within Switzerland that acts on behalf of a non-Swiss manufacturer to ensure that their medical devices and IVDs comply with Swiss regulations. The role of the CH-REP is similar to that of the EC-REP but is specific to the Swiss market.
3. UK-RP (UK Responsible Person)
   A UK-RP, or UK Responsible Person, is a legal entity established within the United Kingdom that acts on behalf of a non-UK manufacturer to ensure that their medical devices and IVDs comply with UK regulations.

In summary, while the roles of EC-REP, CH-REP, and UK-RP are similar in terms of ensuring regulatory compliance and acting as a liaison between manufacturers and regulatory authorities, they are specific to their respective regions and regulatory frameworks. Manufacturers must appoint the appropriate representative based on the market they wish to enter.

EC-REPの主な役割は、メーカーと欧州の規制当局との連絡窗口として機能することです。彼らは、メーカーがEU医療機器規制（MDR）または体外診断機規制（IVDR）に適合するのを支援します。これには、デバイスの登録、技術文書のコピーを保持し、当局とのコミュニケーションを取るなどの作業が含まれます。

EU内に物理的な拠点を持たない医療機器または体外診断機の製造業者はすべて、EC-REPを任命する必要があります。これには、アメリカ、オーストラリア、中国、台湾、マレーシア、イスラエル、インド、日本などの国に拠点を置くメーカーが含まれます。EFTA諸国に物理的な拠点を持つメーカーは、EC-REPは必要ありません。

Yes, a manufacturer can change their Authorized Representative by providing timely notification to the new and current Authorized Representative, ensuring a smooth transition without losing compliance.

No, cosmetic products do not require an EC REP. They fall under different regulatory requirements within the EU. However, a Responsible Person (RP) is required for cosmetics to ensure compliance with safety and regulatory standards.

Post-Brexit, the UK is no longer part of the EU. Therefore, separate regulatory compliance and representation may be required for the UK market, distinct from EU requirements. Specifically, a UK Responsible Person (UK RP) is needed for cosmetics to ensure compliance with UK regulations.

The Authorized Representative acts as the liaison between the manufacturer and EU national competent authorities, managing reports and communications regarding compliance and vigilance.

Yes, the EC-REP (European Authorized Representative) must be included on the device label. This requirement is part of the regulatory framework established by the European Union to ensure that medical devices and in vitro diagnostic devices (IVDs) comply with the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

The inclusion of the EC-REP on the device label provides a clear point of contact within the EU for regulatory authorities, healthcare professionals, and users in case of any issues or questions regarding the device.

The device label must include the following information about the EC-REP:

• Name and Address: The full name and address of the EC-REP.
• EC-REP Symbol: The official EC-REP symbol should be displayed next to the name and address to indicate the role of the representative.

Language Requirements:

• The information must be provided in a language that is easily understood by the end-users and regulatory authorities in the EU member states where the device is marketed.