SBS - The best value in QMS software

Manufacturer's agreement with their EU Authorized Representative

D

Dave-h

Involved In Discussions
#1
#1
Good afternoon, has anyone seen a good example of the sort of agreement the we, as a manufacturer (in the UK), would need to have in place with our EU Authorized Representative? Or even a good list of all of the areas that it should cover?

Thanks.
 
Popular whitepapers from DISCUS
Elsmar Forum Sponsor
H

Hissam Mehmood

Registered
#5
#5
shimonv said:
Hi Dave,
Attached is a draft template that I have from MEDNET (EU rep from German). I recommend them.

Shimon
Click to expand...
Hello,

Hope you are well. Would you also have a template for UK responsible person/representative (as an importer of products from a manufacturer outside the UK) under the new rules from 1 Jan 2021?
 
H

Hissam Mehmood

Registered
#6
#6
Hello,
Can someone please share the template for the agreement to appoint a UK responsible person/representative under the new MDR rules from 1 Jan 2021?

Rgards,
Hissam Mehmood
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
K Quality Agreement MDR - The manufacturer is outside of EU Other Medical Device Related Standards 4
K Supply Agreement Regarding MDR 2017/745 - Manufacturer-supplier cooperation Other Medical Device Related Standards 0
J EC Certification transfer from CMO to Legal Manufacturer Possible? CE Marking (Conformité Européene) / CB Scheme 0
J How to keep MDD certificate valid when legal manufacturer has liquidity problem EU Medical Device Regulations 0
K Penalty to MD distributor or manufacturer? CE Marking (Conformité Européene) / CB Scheme 3
S Distinction between a critical supplier and a Virtual manufacturer EU Medical Device Regulations 2
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
A ISO 13485 Certification for Resin Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 4
M How Specific in an ISO 13485:2016 Scope for a Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 9
G Launching a Legal Manufacturer (Dos and Donts) EU Medical Device Regulations 1
R What information do i need to get from the device manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
Ron Rompen Calibration by manufacturer ISO 17025 related Discussions 4
H Obligations as a contract manufacturer during an MDSAP audit ISO 13485:2016 - Medical Device Quality Management Systems 5
H 510k with Contract Manufacturer Other US Medical Device Regulations 2
P Best european location to set up for a virtual medical device manufacturer? EU Medical Device Regulations 4
F How to submit a PPAP when a subcontractor is the sole manufacturer IATF 16949 - Automotive Quality Systems Standard 2
V UDI - OEM or OBL / Legal Manufacturer Responsibility CE Marking (Conformité Européene) / CB Scheme 0
LostLouie Manufacturer divorced from Design process, is he justified in design process deficiencies? ISO 13485:2016 - Medical Device Quality Management Systems 9
E Contract manufacturer FDA requirements foreign company US Food and Drug Administration (FDA) 6
M We are looking for a Contract Manufacturer US Food and Drug Administration (FDA) 2
D Relabelling a component that will be sold as a spare part - Do I become legal manufacturer? EU Medical Device Regulations 2
A Can a US manufacturer put export only products on a CFG? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
L Sample Procedure from Contract Manufacturer Prospective ISO 14971 - Medical Device Risk Management 1
K Joint approval between OEM and Manufacturer on Design Documents ISO 13485:2016 - Medical Device Quality Management Systems 4
K Legal manufacturer vs Actual manufacturer EU Medical Device Regulations 4
U CFS and Legeal manufacturer EU Medical Device Regulations 6
I Is the contract mfg. mentioned in legal manufacturer EC certificate? CE Marking (Conformité Européene) / CB Scheme 4
S Can a Contract Manufacturer "release" product on behalf of client to the market? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
K 510K new manufacturer but same components Other US Medical Device Regulations 6
A Legal Manufacturer Medical device US Food and Drug Administration (FDA) 2
F How to register class I device to all European Competent Autorities(CA) when we are European manufacturer EU Medical Device Regulations 4
Q Legal Manufacturer OTC Drug Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
R FCC certification (contract manufacturer) TL 9000 Telecommunications Standard and QuEST 1
A Interpretation of GMP Requirements for class 1 medical device manufacturer (device GMP exempt, only General controls applicable) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
A Legal Manufacturer of a medical device Vs Legal Manufacturer of MDSW EU Medical Device Regulations 8
H Who should be listed as the manufacturer/distributor on the box? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
H MDD CM, MDR manufacturer. 2020. Is it ok? EU Medical Device Regulations 1
C FDA Establishment registration - Buying some medical devices from another manufacturer Medical Device and FDA Regulations and Standards News 5
R Impact of changing manufacturer post clinical investigation CE Marking (Conformité Européene) / CB Scheme 3
N Competent Authority notification for non-EU manufacturer EU Medical Device Regulations 4
N Updating the website of the manufacturer EU Medical Device Regulations 1
A MDR Article 22 applicability - Legal manufacturer EU Medical Device Regulations 8
samarth IVD manufacturer and service provider ISO 14971 - Medical Device Risk Management 2
M Contract manufacturer MDR Quality Management System (QMS) Manuals 1
J Complaints and not the legal manufacturer? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 20
M Using your Manufacturer's ISO certification ISO 13485:2016 - Medical Device Quality Management Systems 5
M Is Harmonised EN 1041 (Information Supplied By Manufacturer) Worth Looking At? EU Medical Device Regulations 7
D Are we the manufacturer or relabeler? Medical Device and FDA Regulations and Standards News 2
M Manufacturer address on the label Other US Medical Device Regulations 18
K Implant Card - Full Manufacturer's Address - Space issues EU Medical Device Regulations 4

Similar threads

Top Bottom