Updated Europe Harmonised Standards Lists (2012-08-30)

Sam Lazzara

Trusted Information Resource
#1
New lists released 2012-08-30. Go to this folder for consolidated listing and separate listings for each Directive.

Highlights
EN ISO 13485:2012
EN ISO 14971:2012
 
Last edited by a moderator:
Elsmar Forum Sponsor

sagai

Quite Involved in Discussions
#2
Thank you very much for mentioning!

Is there any other way to get these than buying from BSI?
 
Last edited:

Sam Lazzara

Trusted Information Resource
#3
Could be a good time to call your European Notified Body to see how they are going to handle changes to certificates for EN ISO 13485. Strangely, the transition period is over....it was zero (0) days apparently. The harmonisation of the older versions of both standards expired on the same day the new standard was harmonized - 30 August 2012.

The normative sections (requirements) in EN ISO 13485:2012 and EN ISO 14971:2012 do not differ from the pure ISO versions they are based upon (see below). Therefore, these updated versions will not impact conformance with those requirements.

EN ISO 13485:2012 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

However, as pointed out in the updated informative Annexes, some aspects of the applicable European Directives (i.e., MDD Annex II, AIMDD Annex 2, IVDD Annex VI) are "Not covered" by any normative clauses of the standards. Hence, compliance with EN ISO 13485 requirements does not provide presumption of conformity with all the aspects of the applicable Directives.

Therefore, a manufacturer or a Notified Body may have to take additional actions to ensure conformity, and claim or certify conformance, with Annex II/2/VI of the Directives. The Directive requirements must be examined, applied and verified one by one and the solutions adopted must become part of the quality system.

What does this mean? (in my opinion)

Notified Bodies will need to examine how they have been auditing against the MDD Annex requirements to see if the updated informative Annexes might raise the bar with regard to their conformity assessment methods.

Manufacturers should review these updated Annexes to see if they should update their quality system procedures and/or deliverables (e.g., Risk Management Reports) to ensure coverage of the Directive requirements that are not addressed in 13485 or 14971.
 
Last edited:

Ronen E

Problem Solver
Staff member
Moderator
#4
Thanks Sam for the excellent analysis of the situation.

In my opinion it could benefit manufacturers to first study the original EC concerns over these standards coverage of the directives' requirements, e.g. what were the problems and why was the scope reduced the way it was. This may provide valuable insights about particular directive requirements that need attention, and about what must be added on top of the corresponding standards' clauses.

Cheers,
Ronen.
 
Thread starter Similar threads Forum Replies Date
B Updated IATF 16949 - Will IATF 16949 get revised when ISO 9001:202X is released? IATF 16949 - Automotive Quality Systems Standard 4
K Updated MSA with the Annual PPAP validations APQP and PPAP 8
R Do we need issue ECN (Engineering Change Notice) towards updated Material Specification? Design and Development of Products and Processes 2
Ed Panek Compliance with Standards? When a standard is updated/revised CE Marking (Conformité Européene) / CB Scheme 3
R Shall a new UDI-DI be required when stand-alone software device's version is updated? EU Medical Device Regulations 1
P Cenelec updated standard information CE Marking (Conformité Européene) / CB Scheme 1
W Updated EU MDR regulatory matrix wanted ISO 13485:2016 - Medical Device Quality Management Systems 43
dgrainger Informational MHRA updated guidance: Clinical investigations of medical devices – guidance for manufacturers Medical Device and FDA Regulations and Standards News 0
M Informational Updated US FDA Resources for Third Party Review Organizations Medical Device and FDA Regulations and Standards News 0
M Informational MHRA guidance updated to reflect the mDR – Clinical investigations of medical devices – Biological safety assessment Medical Device and FDA Regulations and Standards News 1
dgrainger Informational Updated Borderlines manual - Version 1.22 (05-2019) EU Medical Device Regulations 0
M Which documents must be updated upon product validation? Document Control Systems, Procedures, Forms and Templates 1
M Informational MHRA – Virtual manufacturing of medical devices – Updated guidance Medical Device and FDA Regulations and Standards News 1
M Keeping up with "State-of-the-Art" & updated Standards EU Medical Device Regulations 11
marmotte Malaysia - Auditor Requires an Updated Audit Report Other Medical Device Regulations World-Wide 5
N I updated my Job Description - Critiques Appreciated Career and Occupation Discussions 22
Marc The IAQG OPMT has posted an updated Resolutions Log AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
A Process Changes, but Work Instructions/Process Maps are not updated ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
P Document references need to be updated to correspond to the current year? Document Control Systems, Procedures, Forms and Templates 5
T Notification of affected parties of Updated Documented Procedures ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
M Australian Meddev Regulations Updated 5 Nov 2014 Other Medical Device Regulations World-Wide 0
B Safety & EMC certificate updated when MCU (MIcro-Controller) is changed? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
R EU updated borderline manual - version 1.16 EU Medical Device Regulations 2
R CFDA updated five regulations to be effective from October 1, 2014 China Medical Device Regulations 16
D Effective Date of updated SOP Document Control Systems, Procedures, Forms and Templates 3
E Korean GMP Guideline updated to Second Revision - April 2014 Other Medical Device Regulations World-Wide 1
Sam Lazzara MDD Harmonised Standards (MDD 93/42) not updated since January 2013 EU Medical Device Regulations 4
S FDA releases Updated Laser Products Regulation Other US Medical Device Regulations 1
N IEC 60601-1 , 3rd edition and the FDA - Special 510k to my updated Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 40
C Key Links (Library) to search for updated Clinical Data (Is & IIa) EU Medical Device Regulations 1
S Updated FDA's List of Recognised Standards - August 2012 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
V Updated Clean Room Classification Table of ISO 14644 Other ISO and International Standards and European Regulations 2
P Do You HULU 2? new thread (or updated) After Work and Weekend Discussion Topics 13
H Best place to keep myself updated on EU Regulatory Changes EU Medical Device Regulations 7
D Tracking Updated Standards (EN/IEC...) including Ammendments EU Medical Device Regulations 2
C Keeping Employees Updated on Newly Revised Procedures Document Control Systems, Procedures, Forms and Templates 15
T When will ISO 13485 be updated? Will it be harmonized with ISO 9001? ISO 13485:2016 - Medical Device Quality Management Systems 4
Sam Lazzara Updated list of MDD harmonised standards (June 14, 2010) EU Medical Device Regulations 4
N Marketing Material with Pictures that were Updated ISO 13485:2016 - Medical Device Quality Management Systems 1
J ISO9001 and Corporate Governance - ISO 37000 being developed to guide standardized Corporate Governance (updated thread March 2019) Other ISO and International Standards and European Regulations 12
bio_subbu US FDA's updated Consensus Standards List - 18th March 2009 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
J Draft Guidance: eMDR - Electronic Medical Device Reporting (Updated) US Food and Drug Administration (FDA) 3
S Technical File Review to updated MDD 93/42/EC (Class II medical devices) EU Medical Device Regulations 3
J Concessions - Raising a concession untill the BOM (Bill of Materials) is updated Quality Tools, Improvement and Analysis 1
M Quality Manual Content - Extended debate - Updated Quality Manual for ISO 9001:2008 Quality Management System (QMS) Manuals 177
T Updated MDD "Single Use" definition ISO 13485:2016 - Medical Device Quality Management Systems 4
L List of updated ISO Standards attached - September 2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 0
M PPAP Review Updated yearly but not send to Customer - Is it Right? APQP and PPAP 12
Wes Bucey New warning with updated firefox? After Work and Weekend Discussion Topics 9
J EU Vigilance (updated MEDDEV rev.5) - Internal Forms EU Medical Device Regulations 13

Similar threads

Top Bottom