SBS - The Best Value in QMS software

Need of EU Representative Designation for Turkey?

htcoztrk

Starting to get Involved
#1
Hello to everyone,

We are medical device manufacturer based in Turkey and I was wondering if we are obligated to designated a EU-RPE (Authorised representative) within the MDR. I couldn't find a clear answer to this not in regulation itself or any guide.

I know the MDR defines AR as "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 ..." but as per the decision made by EU-Turkey Customs Union Joint Committee, we are not obligated to designate EU-REP since 2009 within MDD. So I was wondering if this decision still valid or is it void once MDR comes into force?

Kind regards,
Hatice
 
Elsmar Forum Sponsor

koulidis

Starting to get Involved
#2
There is no agreement yet with Turkey and Switzerland for the MDR. It might be in the future. As things stand you need an ECREP.
 

htcoztrk

Starting to get Involved
#3
There is no agreement yet with Turkey and Switzerland for the MDR. It might be in the future. As things stand you need an ECREP.
Thank you for your reply. Actually there has been an agreement for Turkey but not for Switzerland. So Turkey is not obligated to designate an EC-REP under MDR for sales in EU.
 
Thread starter Similar threads Forum Replies Date
K Does OEM/OBL-Relationship need to involve an EU Authorized Representative? EU Medical Device Regulations 11
V Need of EU representative if CE marked Med Device not marketed in Europe EU Medical Device Regulations 8
E Do I need to notify the FDA of Management Representative changes? Other US Medical Device Regulations 3
M New QMR (Quality Management Representative) in need of advice ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
P Does QSE integrated Management System need only one representative? Quality Manager and Management Related Issues 7
T Do we need an SOP for ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
B Do CTQs need to be equipment specific? FMEA and Control Plans 8
K Contract Manufacturer Do they need a complaint procedure? Medical Device and FDA Regulations and Standards News 8
K Screen printing ink and machine selection_ Need help Manufacturing and Related Processes 6
D Do employee training records need to be centralized? IATF 16949 - Automotive Quality Systems Standard 10
H If we use agile - do we still need to document TF as a waterfall just for the notified bodies need? IEC 62304 - Medical Device Software Life Cycle Processes 2
briteme4 AS9102 First Article Inspection - do I need a second reviewer and signer? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
J Furnace repaired - Do I need a new initial TUS? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
B Does FDA Registration QSR need to cover non-medical devices for contract repackager? US Food and Drug Administration (FDA) 1
S Need ISO 15189:2012 Documentation toolkit. Document Control Systems, Procedures, Forms and Templates 0
J Need a contract monitoring Tool General Information Resources 0
P UDI-PI requirements on reusable surgical device, do we need serialisation? ISO 13485:2016 - Medical Device Quality Management Systems 3
J Need Help with FPY Data in Assembly Process Manufacturing and Related Processes 7
W 17025 and NIST handbook relationship (need advice) ISO 17025 related Discussions 8
lanley liao Does all of the suppliers need to integrated into the supplier list qualified of the company? Oil and Gas Industry Standards and Regulations 2
K Need procedure for D&D inputs? ISO 13485:2016 - Medical Device Quality Management Systems 4
S Need help on "Country of Origin" Medical Device and FDA Regulations and Standards News 0
Ed Panek Immediate need for 80601-2-56 Consulting expert. PM me for details Career and Occupation Discussions 0
Tagin You're Gonna Need a Bigger Root Cause Coffee Break and Water Cooler Discussions 12
M PSA Suppliers - CSR matrix and need the quality manual of PSA APQP and PPAP 6
M Need Help With Information Security Asset Risk Register IEC 27001 - Information Security Management Systems (ISMS) 2
K "World Class Product" based QM. I need advice. Quality Management System (QMS) Manuals 14
I Do I need to sign off my annual audit calendar? Internal Auditing 2
P Do we need to retrospectively use the "MD" symbol (indicating device is a medical device) on labels, e.g. finished devices within expiration date? EU Medical Device Regulations 2
M Do I need separation in my circuit with a medical charger? IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
V Certified Auditor - Need of additional certification specific to industry ( GMPs) ASQ vs ECA vs others Professional Certifications and Degrees 1
D Low risk IVD study in the UK, do I need MHRA approval? UK Medical Device Regulations 1
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
J Records Control - Does each individual record need to be numbered? Records and Data - Quality, Legal and Other Evidence 2
N Is there a need for clinical test of Class IIa products (for MDR)? EU Medical Device Regulations 2
J Do Software Subcontractors need to be ISO13485 compliant in the EU? EU Medical Device Regulations 3
K Do I need a "State of the art" plan? CE Marking (Conformité Européene) / CB Scheme 1
S Need advice for schooling Quality Manager and Management Related Issues 5
R What information do i need to get from the device manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
S Need guidance on project ISO 13485:2016 - Medical Device Quality Management Systems 2
H Need MSA 4th ed. compliant attribute MSA template General Measurement Device and Calibration Topics 4
J Need Change Control Yes/No Decision Tree Template ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
C Does an accessory need an IFU if it use is discussed in the Parent device IFU? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
B Countries with no need for FSC (Free sales certificate) Other Medical Device Regulations World-Wide 0
R The term "Benefit Risk Ratio" in EU MDR, do I need to present benefit risk analysis as a RATIO Risk Management Principles and Generic Guidelines 4
A Brexit When does the UK responsible person need to be in place? UK Medical Device Regulations 10
R Do we need issue ECN (Engineering Change Notice) towards updated Material Specification? Design and Development of Products and Processes 2
N IPC-A-630 - Is this free or do i really need to pay for it? Manufacturing and Related Processes 4
C ISO/ IEC 17021 Resource requirement (need help) Document Control Systems, Procedures, Forms and Templates 5
P Need a programmer for QVI's VMS software for optical inspection machine Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0

Similar threads

Top Bottom