NON-EUROPEAN IVD MEDICAL DEVICE MANUFACTURERS
The IVDD 98/79/EC (“In vitro diagnostic” medical device directive), mandatory since December 7, 2003 requires Non-European Medical Device Manufacturers to appoint a European Authorized Representative to enter their product to Europe. (IVDD Article 10.3)
Obelis (O.E.A.R.C.) is the foremost Authorized Representative for your Medical Devices.
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Services for “All IVD’s” (“Self declaration” IVD medical devices)
- European Authorized Representative: A European appointed registered place of business within the EU acting as the legal identity of a non EU manufacturer towards the EU Member State Competent Authorities as a central EU vigilance and contact point in the Community.
- Pre-market notification (registration) of product(s) on behalf of a non EU manufacturer, according to the specific EU regulation requirements the product(s) should comply with. (IVDD 98/79/EC, art.10)
- Market incident reporting and complaint handling coordination. (IVDD 98/79/EC, Annex III, 5)
- Product labeling compliance: European Authorized representative address on the product related printing materials i.e. catalog, instruction sheets, packaging, manuals + verification of labeling compliance (IVDD 98/79/EC, Annex I, 8.4 (a))
- Obelis European Authorized Representative holds the product's Technical File available for the EU Competent Authorities Review for a period ending five years after the last product has been manufactured (IVDD 98/79/EC, article 9.7)
- Observance of the compliance of the non EU manufacturer at all times, once a duly CE marked product is properly put on the EU market.
Additionally, O.E.A.R.C. offers the following “pre-CE marking” free services:
- Identification of product classification
- Identification of the appropriate notified body
- Coordination between the manufacturer and the notified body
- YOU DON'T NEED NOTIFIED BODY SERVICES FOR All IVDs (“Self Declaration”) IVD medical devices.
Services for Annex II List A&B and “Self testing” IVD medical devices.
- European Authorized Representative: A European appointed registered place of business within the EU acting as the legal identity of a non EU manufacturer towards the EU Member State Competent Authorities as a central EU vigilance and contact point in the Community.
- Pre-market notification (registration) of product(s) on behalf of a non EU manufacturer, according to the specific EU regulation requirements the product(s) should comply with. (IVDD 98/79/EC, art.10)
- Market incident reporting and complaint handling coordination. (IVDD 98/79/EC, Annex III, 5)
- Product labeling compliance: European Authorized representative address on the product related printing materials i.e. catalog, instruction sheets, packaging, manuals + verification of labeling compliance (IVDD 98/79/EC, Annex I, 8.4 (a))
- Obelis European Authorized Representative holds the product's Technical File available for the EU Competent Authorities Review for a period ending five years after the last product has been manufactured (IVDD 98/79/EC, article 9.7)v
- Observance of the compliance of the non EU manufacturer at all times, once a duly CE marked product is properly put on the EU market.
Obelis European Authorized Representative offers the following free services:
- Identification of product classification
- Identification of the appropriate notified body
- Coordination between the manufacturer and the notified body.
- YOU NEED NOTIFIED BODY SERVICES FOR “Annex II List A&B” and “Self testing” IVD medical devices”
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