EU MDR - Annex II 3b - What documents fall under this requirement?

MDRexpert

Involved In Discussions
#1
Hi Everyone,

Can someone explain me EU MDR Annex II 3b requirement. What documents fall under this requirement?
To give you an example - We are currently a contract manufacturer for a X company. Under this new regulation our X company requires all the major as well as minor updates notified to them. Can someone explain/share how they see this requirement?

Regards,
Akanksha
 
Elsmar Forum Sponsor

indubioush

Quite Involved in Discussions
#2
Either the technical documentation lives at both sites or just the Company X site. If it is only at the Company X site, then they need to always have the latest documentation in their technical file. This means you will have to share every revision with them.
 

yodon

Staff member
Super Moderator
#4
To address your first question (what documents), I think this would include assembly work instructions, material specifications, in-process and final test procedures, etc.
 
Thread starter Similar threads Forum Replies Date
R MDR, Annex I, 23.1 Interpretation - IFU on the website EU Medical Device Regulations 0
P MDR/IVDR Annex III - Technical documentation on PMS EU Medical Device Regulations 1
D ISO 14971:2019 vs MDR Annex 1, Requirement #4 - "Manufacturers shall inform users of any residual risks" ISO 14971 - Medical Device Risk Management 5
K Applicability of Cybersecurity EU MDR 2017/745 Annex 1 23.4(ab), 14.2(d) CE Marking (Conformité Européene) / CB Scheme 3
K Applicability of eIFU as per EU MDR 2017/745 Annex 1 23.1 CE Marking (Conformité Européene) / CB Scheme 0
K EU MDR Annex 1 Chapter III: Information in the Instructions for Use-23.4 (e) the performance characteristics of the device; EU Medical Device Regulations 1
Rincewind MDR - GSPR - Annex I - Chapter II EU Medical Device Regulations 2
R An indication that the device is a medical device (MDR, Annex 23.2q) - applicable for accessories? EU Medical Device Regulations 5
S Difference between EU-MDR Annex IX and the Annex-combo X&XI EU Medical Device Regulations 2
S EU MDR Annex XIV - Clinical Evaluation Plan - What do these methods mean? EU Medical Device Regulations 12
K Annex XVI Device Transition Timeline under the MDR EU Medical Device Regulations 2
A EU MDR Annex I section 11.3 - Medical Devices labelled as having a specific microbial state EU Medical Device Regulations 7
J MDR Annex VIII, Rule 6 Classification - Implication for lower risk CV products? CE Marking (Conformité Européene) / CB Scheme 3
A EU-MDR Annex I Requirement 10.1(d) EU Medical Device Regulations 3
D Applicable MDR Annex's for Class IIa Medical Devices EU Medical Device Regulations 0
M MDR Annex IX Chapter I, 2.2 (c) - Device identification procedures during manufacture. EU Medical Device Regulations 1
D Example for Accessories of "Annex XVI non-medical devices" and how to classify it now with respect ot EU MDR Other Medical Device Regulations World-Wide 1
L EU-MDR-Annex I - 10.4 (CMR & Endocrine-disrupting properties) - Labeling Content EU Medical Device Regulations 5
T EU-MDR-Annex I - 10.4 (CMR & Endocrine-disrupting properties) EU Medical Device Regulations 0
S MDR Annex II Design & Manufacturing info - 'Adjuvants' definition EU Medical Device Regulations 3
J IVDR and MDR ANNEX I Requirements Template EU Medical Device Regulations 5
C Annex II EU MDR gap analysis EU Medical Device Regulations 7
W MDR Annex I chapter 23.2 (q) - Information required on the label EU Medical Device Regulations 17
K Two FDA questions regarding UDI (and potentially 803.52 MDR) Other US Medical Device Regulations 0
S EU MDR CAPA - GAP Assessment on CAPA SOPs EU Medical Device Regulations 1
M MDR Article 22 Interpretation EU Medical Device Regulations 3
A User interface Language Requirements - EU MDR EU Medical Device Regulations 1
L EU MDR Article 86 PSUR EU Medical Device Regulations 1
S How is the service life for class I reusable medical devices described in MDR? EU Medical Device Regulations 7
S How is the service life described for class I reusable medical devices in MDR? Elsmar Xenforo Forum Software Instructions and Help 1
E Our company is planning to file MDD not MDR next month. Do we require to show chemical characterization report ? CE Marking (Conformité Européene) / CB Scheme 1
S Classification of a product according to MDR EU Medical Device Regulations 3
L Classification under MDR EU Medical Device Regulations 1
I Interpretation of the MDR GSPR 23.4 (u) EU Medical Device Regulations 2
S Converting SOP MDD to MDR Noob ISO 13485:2016 - Medical Device Quality Management Systems 4
K Biological indicator system classification under MDR EU Medical Device Regulations 2
L 'Distributor' definition & MDR/MSR relationship EU Medical Device Regulations 3
A What does this line from MDCG 2020-3 (MDR art. 120 substantial change) mean to you? EU Medical Device Regulations 4
J EU MDR getting closer - Special offer for Elsmar members 10/2020 EU Medical Device Regulations 13
G MDR translation requirements EU Medical Device Regulations 3
rob73 UK Medical Device Regulations Forum - UK MDR Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 3
J Intervertebral body fusion cage, MDR Class II or Class III? EU Medical Device Regulations 4
F MDR GSPR Checklist template EU Medical Device Regulations 4
B Clinical Evaluation Expert Panels - MDR EU Medical Device Regulations 1
M EU MDR - Labilities when a device is discontinued from the Market EU Medical Device Regulations 1
S National registrations for MDR certified devices in absence of EUDAMED EU Medical Device Regulations 2
Z MDR Class Ir deadline (Reusable surgical instruments) EU Medical Device Regulations 27
B MDR equvalent device - can you use a medicine as an equivalent 'device' EU Medical Device Regulations 8
N Harmonized Standards for MDR Certification EU Medical Device Regulations 7
K Is UDI (Unique Device Identifier) symbol mandatory under EU MDR? EU Medical Device Regulations 1

Similar threads

Top Bottom