Harmonised Standard and Essential Requirements

T

The Oracle

#1
Does anyone know if a comprehensive document exists anywhere that shows which Essential Requirement of the Medical Device Directive is covered by which Harmonised Standard?
I know that Europa has full list of standards that can be used to demonstrate compliance with the MDD, but the appear only in Standard Number order.

Thanks
James
 
Elsmar Forum Sponsor
J

jgossett

#2
I think if you dig deeper, you can get a list with their names. Each standard has an annex in the back that cross-references the clauses or subclauses with the essential requirements. However, the standards you use, depend on your product classification and type.

Hope this helps and good luck.
 
F

fuji033 - 2006

#3
Reference Standard

See ISO 16142:2006 Medical devices -- Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
 
T

The Oracle

#4
Thanks for the responses....

.....i am off to buy ISO 16142 and will also check out the sections at the back of the standards to see the link to ER's.

:thanks:
 
Thread starter Similar threads Forum Replies Date
M Harmonised RED Standard ETSI EN 440 - Which Version? Other ISO and International Standards and European Regulations 0
Q IVD vs EMC OJ (Official Journal of the European Union) Harmonised Standard Conflicts EU Medical Device Regulations 1
R Is BS EN ISO 15223-1 a harmonised standard? EU Medical Device Regulations 2
K How to guess when the standard gets harmonised? EU Medical Device Regulations 2
C Appendix Z in Harmonised Standards? EU Medical Device Regulations 13
dgrainger Informational EU published new Harmonised Standards List for the Directives (25/3/2020) Medical Device and FDA Regulations and Standards News 0
M Referencing Harmonised Standards in Declarations of Conformity EU Medical Device Regulations 4
M Is Harmonised EN 1041 (Information Supplied By Manufacturer) Worth Looking At? EU Medical Device Regulations 7
A Timeline for harmonised standards to be published under MDR CE Marking (Conformité Européene) / CB Scheme 5
M Informational Links to recognized / harmonised / consensus Standards for each market Other Medical Device Related Standards 5
J Use of Harmonised Standards (Full or Partial) ISO 13485:2016 - Medical Device Quality Management Systems 1
Q A Resource - Cheap Harmonised ISO and IEC Standards EU Medical Device Regulations 2
Sam Lazzara MDD Harmonised Standards (MDD 93/42) not updated since January 2013 EU Medical Device Regulations 4
G New list (01-2013) of Harmonised Standards for The MDD published EU Medical Device Regulations 18
M Integrating Multiple HSEQ Systems into a Single Harmonised Global System ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
W New harmonised standards MDD and IVDD 2012/C 262 EU Medical Device Regulations 4
Sam Lazzara Updated Europe Harmonised Standards Lists (2012-08-30) EU Medical Device Regulations 3
rob73 Harmonised Standards on DoC (Declaration of Conformity) EU Medical Device Regulations 10
P Increasing Numbers of Harmonised Standards Other Medical Device Related Standards 1
Sam Lazzara Medical Device Harmonised Standards Update - May 2011 CE Marking (Conformité Européene) / CB Scheme 0
M Objections to ISO standards as harmonised standards in the EU - What's your opinion? ISO 13485:2016 - Medical Device Quality Management Systems 11
M Is there an expectation to meet harmonised standards of the Machinery Directive? EU Medical Device Regulations 7
Sam Lazzara Updated list of MDD harmonised standards (June 14, 2010) EU Medical Device Regulations 4
P List of Harmonised MDD Standards CE Marking (Conformité Européene) / CB Scheme 9
K EU - Does the MD label have to be harmonised? EU Medical Device Regulations 2
Ajit Basrur First Public Consultation on Harmonised Classification and Labelling RoHS, REACH, ELV, IMDS and Restricted Substances 0
P Pooled Standard Error - Minitab Statistical Analysis Tools, Techniques and SPC 0
SABRINA DJILALI SAIAH Implementation of the ISAS-MEDIA 9001 standard in a TV channel ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Sidney Vianna Interesting Discussion Should ISO 9004 be changed from a guidance standard to a requirements standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
B European Harmonized vs IEC standard IEC 62366 - Medical Device Usability Engineering 2
Moumen H Variations between ASTM A29 Standard for steel bars and Mill test certificates specs Manufacturing and Related Processes 1
D Which ISO Standard to purchase? ISO 13485:2016 - Medical Device Quality Management Systems 7
K IEC 60601-1:2005/AMD2:2020, Why this standard version is 3.0? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
C Standard -Machinist Handbook Customer Complaints 4
N EN 813, EN 12277, EN 1497 - Testing some harness prototypes to an EN standard Various Other Specifications, Standards, and related Requirements 0
R Remote Audits for ISO 9001 (or any other standard) General Auditing Discussions 31
S Which department should prepare the control plan? could you show me a standard regarding to this matter. FMEA and Control Plans 17
Y Auditory alarm standard IEC 60601-1-8 Reliability Analysis - Predictions, Testing and Standards 0
M Does the ISO 9001:2015 standard require a disaster recovery plan or emergency response plan ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
S Shore A hardness Tester Acceptance Criteria Standard Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 2
Sidney Vianna What ISO Standard (under the TC 176) supports the UN Sustainable Development Goal #10? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 11
John Broomfield Vote - Should ISO9004 Become a Requirements Standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
Q EN ISO 13485:2016/AC:2018 - AC:2018 being stated in the applicable harmonized standard listing Other ISO and International Standards and European Regulations 1
J SAE J1739 standard IATF 16949 - Automotive Quality Systems Standard 2
Marcel DS LV 123 - BMW, AUDI, Mercedes Standard VDA Standards - Germany's Automotive Standards 1
F Standard Calibration Procedures: Recommended Practice ISO 17025 related Discussions 0
M FDA News FDA Releases Draft Guidance Clarifying Application of ISO 10993-1 Biocompatibility Standard Medical Device and FDA Regulations and Standards News 0
Y UL 1998 Standard: software classes Software Quality Assurance 0
G What to do with correction factors overlooked by an accredited standard (6.4.11)? ISO 17025 related Discussions 5
G Copy of withdrawn ISO 9001:1994 Quality Management Standard ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2

Similar threads

Top Bottom