MDR DRAFT DoC

G

gabe2jadyn

Starting to get Involved
#1
#1
Good Morning:

Had anyone put their DRAFT DoC together for the MDR? If so, what verbiage is required for the person signing the document? Is it Company Representative or Person Responsible? Thank you -
 
Download Free White Paper
Elsmar Forum Sponsor
ChrisM

ChrisM

Quite Involved in Discussions
#3
#3
It's as clear as mud in Annex IV of the MDR.... someone who is confident that the product conforms to the EU MDR Regulation and any other applicable (legislative) requirements.
 
P

Philip B

Quite Involved in Discussions
#4
#4
As the DofC is a legal declaration you need someone with the authority to make that legal declaration. Our Managing Director signs ours.
 
G

gabe2jadyn

Starting to get Involved
#6
#6
Good Afternoon: One more question, for the MDR DRAFT DoC, do we need the name and address of the Notified Body or just the name and company ID#? Thank you -
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
C New draft MDR reporting guidance Other US Medical Device Regulations 1
M Clinical evaluation process of FDA and MDR Medical Device and FDA Regulations and Standards News 2
G MDR CE Experation date EU Medical Device Regulations 1
C MDR vs CMDR EU Medical Device Regulations 4
O MDR language requirements EU Medical Device Regulations 12
K Whether the product is an accessory according to the MDR definition EU Medical Device Regulations 3
L Adverse Event Reporting Flowchart (MDR EU) EU Medical Device Regulations 3
Doninina Trend Reporting for medical device class IIb according to MDR EU Medical Device Regulations 4
Ed Panek MDR Delay? EU Medical Device Regulations 2
dgrainger Informational Proposal to address MDR challenges EU Medical Device Regulations 16
goldenguo MDR/IVDR Insurance and Liability for Manufacturers, EU Representative and Importer EU Medical Device Regulations 3
B MDR PSUR versus Canadian Summary report EU Medical Device Regulations 4
C MDR 2017/744 Article 22 EU Medical Device Regulations 3
K Sales of MDD devices with expired CE that are pending MDR certification EU Medical Device Regulations 4
D New Device Post Market Requirement for MDR EU Medical Device Regulations 3
D EU MDR Derogation EU Medical Device Regulations 0
Doninina Risk management file according MDR or ISO 14971:P2019 ? EU Medical Device Regulations 2
M On-demand EU MDR Compliance toolkit with online training courses, templates & document management system Training - Internal, External, Online and Distance Learning 0
M EU MDR (GSPR Checklist) consolidated with TGA EP Checklist EU Medical Device Regulations 5
A PMSR or PSUR for legacy MDD-class I becoming MDR class-IIa EU Medical Device Regulations 8
H MDR clinical evaluation EU Medical Device Regulations 0
M Possible topic for Master thesis topic - MDR and QMS ISO 13485:2016 - Medical Device Quality Management Systems 4
D MDR technical file: does it need to contain duplicates of controlled documents EU Medical Device Regulations 2
D Does the MDR article 10 (14) needs to be documented word for word in a Procedure? EU Medical Device Regulations 1
N Adding New Products during MDR transition period Manufacturing and Related Processes 1
L Internal Audits during the MDR Transition Period EU Medical Device Regulations 5
Z How to keep up with changes on applicable technical standards (EU MDR)? EU Medical Device Regulations 6
S OEM- Virtual Manufacturer contract MDR Quality Management System (QMS) Manuals 0
J TGA CER & EU MDR CER Requirements for Australia Other Medical Device Regulations World-Wide 3
F MDR Distributor EU Medical Device Regulations 6
Y EU MDR Technical Documentation - Defined Review EU Medical Device Regulations 1
A Class 2b medical device - best pathway to obtain CE mark? (2022, MDR 2017/745) CE Marking (Conformité Européene) / CB Scheme 2
M Declaration of conformity MDR EU Medical Device Regulations 10
dgrainger Informational Manual on Borderline for MDR/IVDMDR EU Medical Device Regulations 6
G MDR Requirements for Samples EU Medical Device Regulations 5
C Applicability of classification rule 9 under MDR EU Medical Device Regulations 6
H Is testing according to IEC 60601-1 & IEC 60601-1-2 mandatory for a device being registered under MDR? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
Ed Panek MDR question - Meaning of Stability CE Marking (Conformité Européene) / CB Scheme 6
P Self Certified Class 1 MDR 2017/745 Design Change CE Marking (Conformité Européene) / CB Scheme 2
A EU MDR Annex II and Annex III CE Marking (Conformité Européene) / CB Scheme 6
N MDR requirments EU Medical Device Regulations 0
O MDD products under MDR certificate EU Medical Device Regulations 12
I Where to find MDR compliance device? EU Medical Device Regulations 6
J Conformity assessment route options under the UK MDR 2002 (2002 SI No. 618), as amended UK Medical Device Regulations 1
C Clinical Trial using Prototype devices (EU MDR & ISO 14155) EU Medical Device Regulations 4
M MDR Legal requirements EU Medical Device Regulations 6
Ed Panek MDR Audit Comment EU Medical Device Regulations 9
J Minor / Major findings with MDR EU Medical Device Regulations 4
R MDR Clinical Evaluation Plan EU Medical Device Regulations 6
R EU MDR Article 22 applicability of medical device with components. EU Medical Device Regulations 4

Similar threads

Top Bottom