In February 1996, in response to the EC (European Community) requirements for non-European manufacturers to appoint a European Authorized Representative, Obelis s.a created the Obelis European Authorized Representative Center, OEARC. OEARC is an active member in the E.A.A.R (European Association of Authorized Representatives), and is committed to providing professional and quality-oriented services to all OEARC clients on the terms of this agreement.
Commencement
This document will govern your relationship with Obelis s.a. each time services are provided to you. This document shall become effective on the date received. These Terms of Business shall vary only if expressed in writing, agreed upon, and signed by both parties. The contract makes references and shall be synonymous to: Obelis s.a. (we, us, our) and you (client, clients, your).
Service
We aim to provide the highest quality of service, to identify our client’s objectives, and to assist in achieving them. We make all necessary efforts to create and maintain proper business relationships with our clients for which the basis is good communication.
Communication
We will be able to achieve the utmost results for you only if you will provide us with as much information as necessary.
Any change of policy, objectives, up-dates, new information, and or new circumstances which are relevant for us to know, should be provided by you as soon as possible.
Communication between both parties is essential and taken seriously. Our team is committed to answer your questions or update you on what is happening regarding your interests.
Responsibility
O.E.A.R.C team members play an active part in achieving the ultimate results for our clients; each matter is supervised by a management member personally responsible for the client file.
If that management member is not available, you will always be served by another team member.
Confidentiality and data protection
O.E.A.R.C will keep all information relating to your file confidential. However, we may disclose information to another party if you ask us to do so or if required by law.
As explained below, we may disclose your files to external quality auditors.
Quality
O.E.A.R.C is one of the first European Authorized Representative Centers to obtain ISO 9001:2015 and ISO 13485:2016, the international standards of quality assurance.
O.E.A.R.C has adapted quality systems and procedures to ensure that you receive the highest quality standard of service. Our performances are monitored by both internal and external audits.
Audits involve the inspection of client files. All Audits are subject to strict confidentiality.
If you object to your file being inspected by external quality auditors, please tell us. Unless we are notified, we will assume that you agree to any file being inspected. You may withdraw your consent to inspection at any time.
Your refusal or withdrawal of consent will not affect in any way O.E.A.R.C conduct of the work or the quality of service you receive.
Storage and paper certifications
On completion of a service, O.E.A.R.C will keep all necessary documents, certifications, product technical files, and other papers in order to execute our tasks quickly and efficiently for our clients.
O.E.A.R.C stores files for a minimum period of 5 years according to the regulatory requirements.
Copyrights
All copyrights in documents provided to us will be kept confidential and under the sole proprietorship of the client.
Fees
O.E.A.R.C will provide the most accurate information on the cost of our services.
Our charges are based on:
- O.E.A.R.C Monthly fees.
- O.E.A.R.C Notification fees.
- O.E.A.R.C Declaration fees.
- O.E.A.R.C Hourly fees.
- O.E.A.R.C Service charges.
O.E.A.R.C Monthly fees also cover maintenance fees of MDlaw.eu platform to keep track of applicable EU regulatory requirements for medical and in vitro diagnostic devices.
O.E.A.R.C accounting department is ready to inform you, at any time, of the balance on your account and fee amounts incurred to date.
In respect to our continuous efforts to uphold the requirements and the high quality of service, all fees mentioned in this document are subject to periodic non-retroactive review and may be revised annually based on any revisions to the tasks, responsibilities and requirements introduced by the applicable EC Directives, Regulations, Decisions, Guidance documents or National provisions on the obligations & services mentioned in this agreement.
If the work we are doing for you has not been concluded by the next review date, the new rates will apply to work undertaken after the review date.
O.E.A.R.C charges are exclusive of VAT, traveling expenses, and photocopying charges. Any payment made on your behalf for that type of expense is charged separately.
Competent Authorities could impose Taxes at the moment of a File Submission. These taxes can be reviewed/changed by the Authorities on a monthly basis. When applicable, these will be asked separately by the consultant in charge of the related process and invoiced accordingly.
Disbursements
O.E.A.R.C charges and fees do not include any payments made on your behalf.
You will be asked to provide us with funds for any payment which we are requested to make on your behalf.
Whereas such disbursement is made by us, we will require to be reimbursed by you immediately on request. Transfer fees associated with payments to Obelis s.a. bank
will be covered by the client.
Invoices
O.E.A.R.C invoices the monthly fees two times during the year. Any other service is invoiced separately upon request of starting said procedure.
O.E.A.R.C invoices are sent in electronic format only.
All invoices are due for payment 7 days from invoice date.
If you do not pay a bill on time or do not reimburse O.E.A.R.C for payments made on your behalf, O.E.A.R.C will consider such behavior a breach of the Agreement and reserve the right to stop working for you and to charge you for the full amount of work we have performed until that moment.
In respect to the European Directive 2011/7/EU, any unpaid invoices after a period of 30 days from the date of first remainder will be automatically subject to a late payment fee of 10.50% on the unpaid balance of the invoice(s).
Liability
O.E.A.R.C will require a vendor’s endorsement to your product liability insurance policy on behalf of Obelis s.a to be presented within 30 days after the signature of this agreement.
O.E.A.R.C will be released and discharged in advance and will be held harmless against all loss, costs, and expenses (including reasonable and customary attorney’s fee) arising out of any claims against Obelis s.a, arising out of O.E.A.R.C activity under the signed European Authorized Representative Agreement, except for any claims deriving from any negligent or malicious acts or omissions by O.E.A.R.C.
Questions and complaints
We aim to offer our clients efficient and cost-effective services, but if there is any aspect of our work with which you are not satisfied, please let us know.
You should, in the first place, address any query or complaint to the corresponding team member directly. In most cases they will be able to resolve your query and or complaint with you.
However, if you are not satisfied with the way the matter is dealt with, you should raise the concern with the Deputy Manager of the concerned department.
Withdrawal instructions
You are entitled to change “business” at any time but are responsible for fees and other outstanding payments due to us at time of change. We are entitled to hold any documents, files, papers, until we receive payment in full.
If you desire to cancel your service agreement, you must notify Obelis s.a. 90 days in advance.
Third parties
O.E.A.R.C work will be carried out solely for your benefit and not for the benefit of any third party.
Legal relationship
You acknowledge that nothing in this agreement creates a relationship of employment, partnership, or agency between
you and Obelis s.a, its employees, team members, and or directors.
Applicable law
These terms are governed by the Belgian law and are subject to the exclusive jurisdiction of the Belgian Courts.
O.E.A.R.C will comply with all requirements prescribed by any law or instrument applicable to O.E.A.R.C.