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
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 13
H EU MDR Economic Operator notifications? EU Medical Device Regulations 1
M MDR EU Distributor for our CE Mark product in the for Netherlands EU Medical Device Regulations 1
R Declaration of conformity as per EU MDR (2017/745) CE Marking (Conformité Européene) / CB Scheme 4
K Class III Kit Box - Are translations mandatory under EU MDR? EU Medical Device Regulations 4
B Herbal ingredients MDR EU Medical Device Regulations 0
S MDR GSPR Clause 17 - Software Requirements EU Medical Device Regulations 2
N Which EN ISO 17664 version compliance to EU MDR? Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 3
D Hospital Decontamination and the MDR - Technical Files, UDI and PMS EU Medical Device Regulations 2
K Submission of MDR File - Partner Companies - Computed Tomography (CT) CE Marking (Conformité Européene) / CB Scheme 10
B How to classify a medical device based on MDR? EU Medical Device Regulations 3
A MDR GSPR Checklist wanted EU Medical Device Regulations 3
N EU MDR - Applicability Article 22 Systems and Procedure Packs CE Marking (Conformité Européene) / CB Scheme 4
B EU MDR Perscription product guidance EU Medical Device Regulations 1
cscalise Suggestions for MDR Auditing tools EU Medical Device Regulations 1
M Example of statement for procedure pack MDR Article 22? Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 0
H MDD CM, MDR manufacturer. 2020. Is it ok? EU Medical Device Regulations 1
M MDR, RED and LVD - Should our device comply with them? EU Medical Device Regulations 2
E UK MDR brexit out of sync with EU MDR deadline? Other Medical Device Regulations World-Wide 2
S MDR Delay - MDD design Change? (before new MDR DOA) EU Medical Device Regulations 8
S Class I MDR Article 10 – QMS EU Medical Device Regulations 1
dgrainger Medical Device News MDR postponed - link to Official Journal of the European Union (24-4-2020) EU Medical Device Regulations 2
K Supply Agreement Regarding MDR 2017/745 - Manufacturer-supplier cooperation Other Medical Device Related Standards 0
Ed Panek Medical Device News MDR Delayed 1 year (Posted 4/2020) EU Medical Device Regulations 9
dinaroxentool Former Class I device that is upscaled to IIa if the MDR is delayed EU Medical Device Regulations 2
B FDA-Medical Device Reporting (MDR )procedure compliant with 21CFR section 803 US Food and Drug Administration (FDA) 0
J PPE, the MDR and EU 2016/425 EU Medical Device Regulations 4
R Clinical evaluation without clinical data - MDR Article 61(10) EU Medical Device Regulations 5
dgrainger Informational Postponement of MDR - adopted by the Commission - April 2020 Medical Device and FDA Regulations and Standards News 3
R Applicability of new non-harmonized standards (MDD/MDR) EU Medical Device Regulations 8
F The EU Drafts Bill to Postpone MDR by a Year (3/2020) Medical Device and FDA Regulations and Standards News 2
T Commission proposal being drawn up for postponement for date of application of MDR (2017/745) EU Medical Device Regulations 7
A MDR Article 22 applicability - Legal manufacturer EU Medical Device Regulations 6
M Estimating the benefit-risk ration under MDR EU Medical Device Regulations 1
Similar threads


















































Top Bottom