Annex of ISO 13485:2016 as harmonized standard (MDR/IVDR)

L

Laura19

Registered
The list of harmonized standards shows these elements regarding 13485:
EN ISO 13485:2016,
EN ISO 13485:2016/A11:2021,
EN ISO 13485:2016/AC:2018

Does everyone know the difference between the annexes? Are both applying?

Thank you very much!
 
Ronen E

Ronen E

Problem Solver
Moderator
Laura19 said:
The list of harmonized standards shows these elements regarding 13485:
EN ISO 13485:2016,
EN ISO 13485:2016/A11:2021,
EN ISO 13485:2016/AC:2018

Does everyone know the difference between the annexes? Are both applying?

Thank you very much!
Click to expand...
Regardless of the contents of the newer versions, since the unrevised version EN ISO 13485:2016 is also an item on that harmonized standards list entry, the later revisions are not necessary for presumption of conformity.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
K ISO 13485:2016 Self Certification for Class I (annex 9) Stand-Alone Software? ISO 13485:2016 - Medical Device Quality Management Systems 3
Q What is the difference between MDD Annex II, Sec 3 and ISO 13485 ? ISO 13485:2016 - Medical Device Quality Management Systems 5
M IVD Annex III Path - Suitable Quality System (e.g. ISO 9001, ISO 13485)? EU Medical Device Regulations 2
B Class IIb Medical Device using Annex II route - Need to Update ISO 13485 Scope? ISO 13485:2016 - Medical Device Quality Management Systems 2
S What is the relation between EU Annex 1 and ISO 14644 requirements? Manufacturing and Related Processes 2
B Is 14971 Annex C checklist now in ISO/TR 24971 required to complete prior to 510k filing? ISO 14971 - Medical Device Risk Management 3
K Questions about Table C.1 examples of hazards in Annex C of ISO 14971. 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
R Identify Medical Device characterstics as Annex C of ISO 14971 Risk Management ISO 14971 - Medical Device Risk Management 5
A EN ISO 14971:2019 does not include the Annex Zs ISO 14971 - Medical Device Risk Management 4
FoGia IMDRF opened a Consultation on Annex E & F and the link to ISO 14971 ISO 14971 - Medical Device Risk Management 4
Douglas E. Purdy ISO/IEC 17025:2017 Clause 8 & Annex B ISO 17025 related Discussions 11
Paul Simpson Informational The role of Annex SL - High Level Structure of ISO MSS's - Revision Update February 2019 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
B IFU and deviation 7 in ISO 14971 Annex ZA ISO 14971 - Medical Device Risk Management 1
B Interpreting Deviations 5 & 6 in Annex ZA in ISO 14971:2012 ISO 14971 - Medical Device Risk Management 1
Marc Annex SL - Format for Future ISO Management System Standards Other ISO and International Standards and European Regulations 7
L ISO 14971 - Annex C question C.2.34 "Essential performance" ISO 14971 - Medical Device Risk Management 2
J EN ISO 14971:2012 Annex ZA Deviation #4 Clarification ISO 14971 - Medical Device Risk Management 3
J Annex ZA of ISO 14971:2012 - Deviation 7 - Incorrect Interpretation ISO 14971 - Medical Device Risk Management 10
Sam Lazzara Experiences with Notified Bodies addressing EN ISO 14971:2012 Annex Zs ISO 14971 - Medical Device Risk Management 5
K RISK ANALYSIS SAMPLE according to Annex ZA of EN ISO-14971-2012 Other Medical Device and Orthopedic Related Topics 1
R EN ISO 14971:2012 - Implementing Annex Z content deviations ISO 14971 - Medical Device Risk Management 1
I IVD (in vitro diagnostic) Checklist for ISO 14971:2009 Annex H ISO 14971 - Medical Device Risk Management 3
L ISO 17021:2011 - The Application of Annex A - Work Instruction Details General Auditing Discussions 9
C List of Potential Hazards Definitions in Annex E of BS EN ISO 14971:2009 ISO 14971 - Medical Device Risk Management 4
C Corrective action in control plan per Annex A of ISO/ TS 16949: 2002 standard FMEA and Control Plans 4
B ISO 9001:2000 Requires ISO 14001? Annex A, Page 15 of ISO 9000:2000 Miscellaneous Environmental Standards and EMS Related Discussions 5
I Classification of device per Annex 8 of the EU MDR EU Medical Device Regulations 4
B 62368-1 Annex V1.6: "Terminals intended to be used by an ordinary person" CE Marking (Conformité Européene) / CB Scheme 4
O 61010-1 Annex D Protection between HAZARDOUS LIVE circuits and ACCESSIBLE external TERMINALS Other Medical Device Regulations World-Wide 0
dgrainger Informational Published - Common specifications for the groups of products without an intended medical purpose listed in Annex XVI EU Medical Device Regulations 1
E EN 868-5:2018 Annex E - Peel Test Design and Development of Products and Processes 6
A Annex II and Annex III - PMS - Duplicate? EU Medical Device Regulations 1
A EU MDR Annex II and Annex III CE Marking (Conformité Européene) / CB Scheme 6
I MDR Audit: NC per MDR Annex IX Administrative provisions 8. EU Medical Device Regulations 6
Y Relationship Between Appendices to Annex XVII and Annex XVII of REACH regulation REACH and RoHS Conversations 0
C MDR - Annex II _3. DESIGN AND MANUFACTURING INFORMATION_a EU Medical Device Regulations 3
dgrainger Informational DRAFT - Common specifications for the groups of products without an intended medical purpose listed in Annex XVI. EU Medical Device Regulations 0
adir88 Substantial Change to QMS (Annex IX, Chapter I) EU Medical Device Regulations 0
M Annex X section I.I d of Directive 93/42/EEC EU Medical Device Regulations 3
J Translation requirements for the statement referred to in ANNEX XIII of MDR EU Medical Device Regulations 0
C REACH Annex XVII vs XIV RoHS, REACH, ELV, IMDS and Restricted Substances 1
A MDR ANNEX XI part A or Part B EU Medical Device Regulations 0
S EU MDR Annex I Chapter III 23.4 z EU Medical Device Regulations 3
C EU MDR - Annex II 6.1 Pre-clinical and clinical data EU Medical Device Regulations 4
K Section 13.6 Annex 1 MDD 93/42/EEC for Glove EU Medical Device Regulations 0
D Is PMCF really a continuous activity per Annex XIV,Part B? EU Medical Device Regulations 5
R MDR, Annex I, 23.1 Interpretation - IFU on the website EU Medical Device Regulations 5
L EN 62368 (In an Annex - M.4.2.1) Secondary Lithium Battery Charging Safeguards CE Marking (Conformité Européene) / CB Scheme 2
P MDR/IVDR Annex III - Technical documentation on PMS EU Medical Device Regulations 2

Similar threads

Top Bottom