What is a EC representative?
A European Authorised Representative may also be known as a EUAR, EC REP, CE REP, EU REP and also an EAR. Your European Authorised Representative (EC Rep) provides a point of contact between you (the non-European medical device manufacturer) the national Competent Authorities (Ministry of Health) and Notified Bodies.
What is the role of an authorized representative?
An authorized representative’s primary role is to represent an individual or company in different official transactions. They have the authority to communicate, liaise, negotiate, and make decisions according to goals and project requirements.
What is an authorized representative for medical device companies?
“’authorized representative’ means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer’s behalf in relation to specified tasks with regard to the latter’s obligations […]”.
Who is a legally authorized representative?
Legally authorized representative (LAR) means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research (45 CFR 46.102(c)).
What is the meaning of authorized person?
More Definitions of Authorized Person Authorized Person means employees or agents including investment managers as have been designated by written notice from the Customer or its designated agent to act on behalf of the Customer under this Agreement.
Is EC Rep mandatory?
Is it mandatory? Yes, it is required at the port of entry. The European Representative has the authority to register non-EU manufacturers and medical devices with EU authorities.
What are the 5 five most basic services of an European Authorized Representative?
What is a European Authorized Representative?
- Providing a registered address within the European Union.
- Keeping all technical documentation available for inspection by the European Authorities.
- Completing notifications to European Authorities.
- Completing any registrations to national databases.
Is a spouse an authorized representative?
You may grant your spouse or another family member permission to speak on your behalf as an authorized representative, even if you plan to handle your health insurance on your own.
Is a parent a legally authorized representative?
A legally authorized representative is an individual who, under law, has the ability to act on behalf of another person (such as a minor study participant). The LAR may be a parent, grandparent, caregiver who has the legal authority to grant consent on behalf of another who has been invited to participate in research.
Who is an Authorised person answer?
Section 2(c) of the Foreign Exchange Management Act or FEMA states that ‘authorized person’ means an authorized dealer, money changer, off-shore banking unit, or any other person authorized under section 10 (1) to deal in foreign exchange and foreign securities.
What is an authorized representative for a business?
An authorized agent or authorized company representative is a person who is a principal executive officer or other corporate officer with signatory powers as per the company’s by-laws or per a vote of the directors if the company is a corporation; a general partner or proprietor if the company is a partnership or sole …
Who is the European Authorized Representative ( EC Rep )?
The appointment of an European Authorized Representative ( EC REP) for the Member States of the EEA is a requirement of the European Medical Device Regulations – Medical Device Regulation ( MDR (EU) 2017/745) and In Vitro Diagnostic Medical Device Regulation ( IVDR (EU) 2017/746 ), to fulfill one aspect of the requirements for CE marking.
What are the duties of an EC Rep?
The EC REP performs certain duties under the European Medical Devices Regulations and acts as a legal interface between the Medical Device manufacturer and the EU Authorities. Appointing MDSS as your EC REP will effectively put your company on the forefront of European Regulatory Requirements.
What are the duties of an authorized representative?
Establish Mandate with MDSS contact. 3. The authorized representative shall perform the tasks specified in the mandate agreed between it and the manufacturer. The authorised representative shall provide a copy of the mandate to the competent authority, upon request. Tasks are outlined in the contract mandated. 4.
Can a distributor Be Your European Authorized Representative?
It is possible to appoint a distributor as your Authorized Representative in Europe; however, it is not recommended because most distributors are not prepared to fulfill the mandatory responsibilities of the EC REP. Instead, select an independent representative that focuses on regulatory affairs, rather than sales and marketing.