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Obelis (ISO Certified and E.A.A.R. member) services include: E.A.R. services, CE marking consulting, EU Harmonized Standards Identification, P.M.S, Free Sales Certificate, GMDN Code Research, Device Registration, Trade Mark Submission, and more.

Device Classification Confirmation Services

One of the most concrete examples of the importance of proper classification resides in the MDD 93/42/EEC which requires of medical device manufacturers to classify their devices before placing their products in the European Union. This classification is extremely important and will determine the compliance route for CE marking and market placement.

MDD 93/42/EEC Services

Services offered by Obelis in accordance to the Medical Device Directive 93/42/EEC and its amendment 2007/47/EC include, but are not limited to European Authorized Representative services (EC Rep), pre-market notification of Class I devices and notification of the preliminary clinical investigations, post market advisory services, pre-CE marking services, free sales certificate services, certificate of CE registration, and GMDN code research services.

AIMDD 90/385/EEC Services

Obelis European Authorized Representative Center provides superior quality representation, notification, and regulatory services for the successful introduction of your medical devices within the European territory. Our services are backed by 20 years experience giving regulatory, CE marking consulting, and European Authorized Representative services. We are located within a walking distance of the European Commission, maintaining close relations with the EU Administration.

IVDD 98/79/EC Services

Services offered by Obelis in accordance with the In-Vitro Diagnostics Directive 98/79/EC include, but are not limited to European Authorized Representative services (EC Rep), pre-market notification to the Member State Competent Authority (per Member State), post market advisory services, pre-CE marking services, free sales certificate services, certificate of CE Registration, and GMDN code research services.

Cosmetic 76/768/EEC Services

Services offered by Obelis in accordance with the Cosmetics Directive 76/768/EEC include, but are not limited to European Authorized Representative services, pre-market notification with Member State authorities and anti-toxic centers (per Member State) ,post market advisory services, and more.

MSD 98/37/EC Services

Services offered by Obelis in accordance with the Machinery Safety Directive 98/37/EC and its amendment 2006/42/EC include, but are not limited to European Authorized Representative services, post market advisory services, pre-CE marking services, and free sales certificate services.

EMC 2004/108/EC Services

Services offered by Obelis in accordance with the Electromagnetic Compatibility Directive 2004/108/EC include, but are not limited to European Authorized Representative services, post market advisory services, pre-CE marking services, and free sales certificate services.

LVD 2006/95/EC Services

Services offered by Obelis in accordance with the Low Voltage Directive 2006/95/EC include, but are not limited to European Authorized Representative services, post market advisory services, pre-CE marking services, and free sales certificate services.

R&TTE 1995/5/EC Services

Services offered by Obelis in accordance with the Radio and Telecommunications Terminal Equipment Directive 1995/5/EC include, but are not limited to European Authorized Representative services, post market advisory services, pre-CE marking services, and free sales certificate services.

GPSD 2001/95/EC Services

Services offered by Obelis in accordance with the General Products Safety Directive 2001/95/EC include, but are not limited to European Authorized Representative services, post market advisory services, free sales certificate services and more.

PPE 89/686/EEC Services

Services offered by Obelis in accordance with the Personal Protective Equipment Directive 89/686/EEC include, but are not limited to European Authorized Representative services, post market advisory services, pre-CE marking services, and free sales certificate services.

CPD 89/106/EEC Services

Services offered by Obelis in accordance with the Construction Products Directive 89/106/EEC include, but are not limited to European Authorized Representative services, post market advisory services, pre-CE marking services, and more.

PED 97/23/EC Services

Services offered by Obelis in accordance with the Pressure Equipment Directive 97/23/EC include, but are not limited to European Authorized Representative services, post market advisory services, pre-CE marking services, and free sales certificate services.

TSD 88/378/EEC Services

Services offered by Obelis in accordance with the Toy Safety Directive 88/378/EEC include, but are not limited to European Authorized Representative services, post market advisory services, pre-CE marking services, and free sales certificate services.

US Agent Services

The primary function of a U.S. Agent as defined in the federal regulations is to serve as a point of contact for the FDA in communicating with a foreign device manufacturer. The U.S. Agent must have a domestic U.S. street address (no post office box number). The U.S. Agent will be contacted, whenever the FDA cannot contact the manufacturer directly. The U.S. Agent will also assist in scheduling FDA inspections of the manufacturer’s facilities.

Free Sales Certificate Services

Many non-European countries request a personalized Free Sales Certificate from the manufacturer in order to place their device within that specific country.

CD of Essential Requirements for MDD & MSD

Services for Device Registration in Italy

Placing your medical device into the European market is contingent upon your compliance with the Medical Device Directive (93/42/EEC). While this Directive is a law to all 27 member states within the European Union, each member state has its own way of implementing the Directive within their country, essentially adding regulations to the Directive and creating Local Legislation.

Trade Mark Services

Obelis offers the possibility to register your trade mark and design in the EU. As a non-European manufacturer, you need to appoint a European Representative to register your trade mark and community design.

Environmental Directives Services

GiDoS Green Regulatory Center is a quality driven, service oriented company dedicated to assisting European and non-European manufacturer’s successful compliance with Environmental Directives and Regulations within Europe.

Post Market Surveillance

Systematic procedure to review experience gained from devices in the post-production phase” MEDDEV 2.12-1 rev 4 April 2001 Post Market Surveillance (P.M.S.) is a continuous product assessment designed to give the manufacturer ongoing feedback about the efficacy of their product. Analysis can lead to design improvements, safety innovations, and increased understanding of consumers.

Services provided by Obelis