Legal requirements for selling medical devices within the European Community
By CE marking the manufacturer declares the conformity of his medical device directives MDD 93/42/EEC of the European Community. Prior to CE marking a conformity assessment described in the directives must be completed for each device.
Only medical devices within the scope of these directives can be CE marked. CE marking must not be applied to products that do not fall under the directives.
Once a medical device is CE marked – either by self-declaration for class I medical devices or in cooperation with your Notified Body for devices classed as Is, Im, IIa, IIb, III – sales in Europe is allowed after CE registration with the relevant competent authorities.
Medical devices must be registered with the Competent Authorities before being placed on the market.
DENTEQ as your EC Representative will perform this national product registration as part of our Authorized Representation Services.
According to the European directives an European Authorized Representative has to be designated by a manufacturer of medical devices that is not located within the European Community.
You must retain an EC REP as long as you sell your devices in Europe
The specific tasks of the European Authorized Representative are described in the medical device directives MDD 93/42/EEC.
Our EC-REP services for your successful entry into the European market
DENTEQ as your Authorized Representative
For medical devices acts as your legal entity towards the European authorities and fulfills on your behalf the obligations described in the Medical Device Directive MDD 93/42/EEC as well as additional services regarding the marketing of your medical devices within the European Community.
DENTEQ EC-REP Services for Medical Devices
- product registrations to the EU Competent Authorities (DIMDI database)
- guidance in the preparation of Declarations of Conformity
- guidance in the labeling and language requirements in Europe
- contact person for inspections and audits by Competent Authorities
- presenting a current copy of your Technical File or CE Declaration of Conformity during audits
- Assistance with Incident and Field Safety Corrective Action (FSCA) reporting
- a small monthly base fee is due and covers the EC-REP status, product marking and contact availability for incidents reporting and national authorities
- registration related work, incident handling and reporting, audit support etc is charged as required at a fixed hourly rate
- registration fees and audit fees by national authorities are charged on proof
- no additional work – no additional costs
DENTEQ your reliable partner for representing your medical devices in Europe
The following steps must be completed by the manufacturer:
- The product must be correctly classified
- A Notified Body must be involved (for products other than class I) and the Technical File including the Declaration of Conformity must be prepared
- The CE mark must be affixed and correct product labeling completed
- The Authorized Representative must be asigned and included in the manufacturer’s product liability insurance
- An agreement between manufacturer and DENTEQ has to be signed