M. Devices Ltd
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European Union Authorised Representative Service Agreement
Agreement made between the Client:____________________________________________________________________________(Your
Company Name)
Address:__________________________________________________________________________(Your
Company Address)
Tel No:___________________________________
Fax No:_____________________________(Your Tel & fax Nos.)
And
The Provider: M. Devices Ltd (herein referred to
as MDG)
Marlborough, Riding Street, Southport, PR8 1EW, England.
Phone: +44 1704 544 944
Fax: +44 1704 544 050
From USA Tel: 01144 1704 544 944 From USA Fax: 01144
1704 544 050
E-mail: euarep@mdevices.net
Services to be provided:
- MDG will act as the client's European Union Authorised Representative.
- Register your devices with the Competent Authority.
- Under Article 14 of the Council Directive 93/42/EEC will report incidence,
complaints and other notifications to the relevant Competent Authority for
you our client, with your agreement.
Help with Reporting:
- MDG will provide guidance to you our client where required, as to what
events, incidence, complaints are reportable and copies of the Medical
Device Vigilance guidelines publication.
What do you need to do:
- If you are the manufacturer or distributor, first placing the
devices in the market, you must ensure that your organisation, your
distributors and their customers have procedures in place which will permit
the reporting of all reportable events to MDG, your European Union
Authorised Representative.
How to report:
- We will provide you with copies of the Medical Device Vigilance
guidelines, which provide templates for reporting all reportable events.
How to label & packaging on your Devices:
- You need to clearly state the contact information:
European Union Authorised Representative
M. Devices Ltd
Marlborough House, Riding Street, Southport, PR8 1EW, UK.
Tel: +44 1704 544 944 Fax: +44 1704 544 050Your contact
in MDG:
- Is Paul Shane Bennetts who will liaise between you and MDG's technical
client advisors.
Our Promise:
- To provide you with a responsive, professional, helpful and friendly
service.
- To help you find answers to questions you may have, either through
ourselves or through other parties we know of.
- To acknowledge your faxes and emails within 24 hours.
- To listen carefully to any complaints you may have about our service and
to respond to you within three days with corrective action and a genuine
apology.
Periodic Reviews:
- We will undertake an annual review of your product ranges to check that
your declaration remains current.
The Cost:
- Your annual fee is $2,000.
- There are no extras or hidden charges, you will not pay any other costs
other than any Competent Authority's Fees on Registration (presently approx.
US$130).
- In return we ask you to sign this 3 year agreement and the annual fee will
remain fixed for the three year period.
When and How do you pay:
- You pay your annual fee each year on the commencement date &
anniversary of this agreement.
- Payment is by wire transfer from your bankers to MDG’s:
Lloyds Bank PLC, 128 Lord Street, Southport, PR8 1AB, UK.
- Bank Account No: 011280503 Sort Code: 30-97-88
- Commencement date: Is the date you sign this agreement.
Increases:
- After three years increases will only reflect any inflationary rises.
- You will always be given 90 days to consider renewing your agreement.
- You will be given the opportunity to accept a further three year fixed
price agreement at the end of this agreement.
Confidentiality & Liability:
- Both parties agree not to disclose any confidential or proprietary
information under this agreement to third parties unless required to by law.
- Advice and information provided by MDG is without liability.
Termination & Jurisdiction:
- Either party may terminate the agreement by giving notice in writing to
the other party 90 days before the renewal date of this agreement.
- This agreement is subject to the laws of England and Wales.
Signed on behalf of M. Devices Ltd: 
Name: Paul Shane Bennetts Title: Managing Director
Accepted on behalf of:
Signature: ______________________________Commencement date:____________
Name: _________________________________ Title:_________________________
Witnessed by:
Signature: _____________________________________
Name: ____________________________ Title:_________________________
Special People make our Service
Special
M. Devices Ltd is a Company Registered in England.
Reg No. England 3693058 Registered Office: Marlborough House, Riding Street,
Southport, PR8 1EW.
Invoice
[Please complete your name, address & enter date of
accepting above Agreement on invoice]
| Authorized Representative Provider |
Customer Invoice |
INVOICE DATE:
INVOICE NUMBER:EUAUTHREP2000 |
M. Devices Ltd
HEAD OFFICE
MARLBOROUGH HOUSE
RIDING STREET, SOUTHPORT,
Tel: + 44 (0)1704 54 49 44
Fax: + 44 (0)1704 54 40 50
PR8 1EW UK
E mail: euarep@mdevices.net
V.A.T. NUMBER: GB 712 5746 42 |
Name:
Address:
|
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| DESCRIPTION OF SERVICES & PRODUCTS |
European Union Authorised Representative Service |
Total |
| Commencing on the _______________________ |
for a period of 12 months |
US $ 2,250.00
Plus Registration Fees US $ 130.00
Total US $ 2,380.00
|
Payable by Wire Transfer to
M.Devices Ltd,
Lloyds Bank PLC,
128 Lord Street,
Southport, PR8 1AB,UK
Bank details supplied separately by email |
Payment Terms:
Payable on date of signing agreement
Thank you for paying on time |
PLEASE FAX OR EMAIL A COPY OF THIS INVOICE
WITH YOUR SIGNED AGREEMENT
EMAIL:euarep@mdevices.net
FAX: 001 44 17 04 54 40 50 |
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BETTER REGULATORY ADVICE,
LEADING TO FULL COMPLIANCE
PROVIDING COMPLETE CUSTOMER
SATISFACTION
Please recommend our work to a colleague |
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