EUROPEAN AUTHORIZED REPRESENTATIVE (EAR) & US FDA Agent

The Authorized Representative performs product registrations or notifications into the relevant data bases of the European Countries and to the authorities in all EU Member States.

The European Representative assists manufacturers in all aspects of the necessary vigilance requirements such as incident reporting and acts as a contact point for authorities. All communication with the authorities is required to be done via the Authorized Representative.

• Authorization to place its name, address, phone number on your device primary and Secondary information panels.
• Acting as your primary contact point for the European Region.
• Registering of your Risk Class I devices with the Authorities before they are marketed.
• Keeping your technical file documentation ready and available for the European Competent Authorities.
• Notification of serious device incidents to the Competent Authorities.
• Notification of changes and amendments to the Medical Device Directive that affect your device(s).

Step 1- Signing of Agreement between the manufacturer and the Authorized Representative listing the duties and responsibilities of both sides.

Step 2- After signing the contract, the manufacturer submits necessary documentation according to a check-list provided by EUROPECERT.

Step 3 – EUROPECERT as your European Authorizes Representative performs the product registration and free sale Certificate

No, they do not sell products and they do not compete with your distributors and or agents.

First, you choose an Authorized Representative that is experienced and well versed in the areas of Medical Devices and knowledge in technical files and design dossier. Then you draw up an agreement clearly outlining the essential duties of the Authorized Representative in accordance with the requirements in the Medical Device Directive or Medical device Regulation.

• Device compliance with the Medical Device Directive requirements.
• Placing of your technical documentation in its trust.
• Immediate notification of device incidents.
• Full cooperation with requests from the Competent Authorities
• Product Liability Insurance coverage that includes the EU.
• Indemnification of product liability.

Confidentiality should be covered in the agreement between your company and the Authorized Representative in accordance with the Medical Device Directive which states that all EAR, authorities included, are bound to observe confidentiality with regard to all information provided and furnished in the technical file.

The EU Representative and the manufacturer are both obliged to end the infringement under conditions imposed by the member state such as a letter of warning, penalty, sales ban etc.. Plus the manufacturer placing its name on the device.

Yes, as per MDD. The medical device directive requires that the manufacturer plus the Authorized Representative names be printed on the device label, with the result that both parties are held liable. To prevent duplication of liability insurance for the same device the Authorized Representative becomes an additional insured under the manufacturer's worldwide policy.

The EU Representative is subject to EU law. The device manufacturer, however, resides outside the EU Legal Jurisdiction and may decide not to cooperate with the EU authorities. To minimize the Authorized Representative's exposure of being on the receiving end of a manufacturer's liabilities, the penalty clauses provide recourse.

No, the Authorized Representative's name remains on devices already sold and still in use, resulting in the continuation of some obligations even after the cancellation of the agreement.

• Class I – 850 Euros / Year
• Class Is / Im – 900 Euros / Year
• Class IIa – 1100 Euros / Year
• Class IIb – 1300 Euros / Year
• Class III – 1400 Euros / Year

MDD requirement and compliance to CE Marking allows access to the EU market (according to Article 14 MDD 93/42/EEC as amended by the 2007/47/EC and Article 10 IVDD 98/79/EC).

CE Certification only enables penetration to the European market and not to other global markets such as the Middle East and African countries. Due to the high standards and popularity of CE Marked Medical Devices, the non-EU countries request a Free Sale Certificate from the manufacturer to demonstrate the medical device meets MDD requirements.

With a Free Sale Certificate (FSC) manufacturers can penetrate the market of the relevant country and be freely sold to the public presuming all local requirements are also met.

Inorder to apply Free Sale Certificate, your firm must appoint EUROPECERT as your Authorised European Representative (EAR)

Any class of Medical Device 3500 Euros / TWO UMDNS or GMDN product code.
Additional medical devices 200 Euros / Product Codes

The above fees are for ONE COUNTRY attestitation. Additional each country 1000 Euros.