Is it mandatory to obtain ISO13485 certificate prior to CE marking?

Elsmar Forum Sponsor

RA_QA_Expert

Starting to get Involved
#2
Hi, the certification is voluntary.

The certificate is usually requested by customers or national authorities during registration processes in non-EU countries.

For EU and CE marking, you need to meet MDD/MDR requirements relating the QMS. You should follow ISO13485, but certification is not requesred.
 
#3
Hi, the certification is voluntary.

The certificate is usually requested by customers or national authorities during registration processes in non-EU countries.

For EU and CE marking, you need to meet MDD/MDR requirements relating the QMS. You should follow ISO13485, but certification is not requesred.
Thank you! Your answer is very helpful :)
 
#4
Yes, it is not mandatory, but to obtain the CE certificate from a NB they will want to see evidance of your QMS. If it not ISO 13485 certified, you will have to convince them that your QMS is equally good to that standard or better. It is very hard to achieve this way, the easier way is to get ISO 13485 certified.
 

Sicco

Involved In Discussions
#5
Yes, it is not mandatory, but to obtain the CE certificate from a NB they will want to see evidance of your QMS. If it not ISO 13485 certified, you will have to convince them that your QMS is equally good to that standard or better. It is very hard to achieve this way, the easier way is to get ISO 13485 certified.
Wrong!
You are not right that ISO 13485 is mandatory as RA_QA_Expert has mentioned above it is voluntary but you have to prove you fulfil requirements of MDD/MDR on your quality system and it is more easier if you have certification according to the standard.
 

Cari Spears

Super Moderator
Staff member
Super Moderator
#8
Wrong!
You are not right that ISO 13485 is mandatory as RA_QA_Expert has mentioned above it is voluntary but you have to prove you fulfil requirements of MDD/MDR on your quality system and it is more easier if you have certification according to the standard.
Starting a reply with "Wrong!", is not going to be well received, even if someone is mistaken.
 
Thread starter Similar threads Forum Replies Date
earl62 What is the best way to control special characteristics in Control plan? Is it Mandatory to have SPC for IATF 16949? IATF 16949 - Automotive Quality Systems Standard 5
K Is UDI (Unique Device Identifier) symbol mandatory under EU MDR? EU Medical Device Regulations 1
K Class III Kit Box - Are translations mandatory under EU MDR? EU Medical Device Regulations 5
M When is EN 62133-1 (new version i.e. IEC 62133:2017) mandatory in EU Other ISO and International Standards and European Regulations 0
S Mandatory documents vs shall "something" but without mandatory documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
O Is it mandatory for Medical Devices to work properly after dielectric strength tests? IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
M What is PESTLE Analysis and is it mandatory? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
F ISO 17025:2017 mandatory documentation requirements ISO 17025 related Discussions 1
D Is Human Factors testing mandatory for a 510(k) submission? Human Factors and Ergonomics in Engineering 16
Kuldeep Singh Mandatory Documents for EU authorized Representative under MDR CE Marking (Conformité Européene) / CB Scheme 8
Sidney Vianna Interesting Discussion Hello IAF. Are you listening? Please explain the inconsistency in your IAF Mandatory Documents (2019) ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 6
M Informational Health Canada – Mandatory reporting requirements for hospitals Medical Device and FDA Regulations and Standards News 0
Sidney Vianna The mystery of an IAF Mandatory Document disappearance ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 6
S IATF 16949: Is "Certified" Internal Auditor mandatory? IATF 16949 - Automotive Quality Systems Standard 9
R US FDA Mandatory Labelling contents for an OTC medical device US Food and Drug Administration (FDA) 0
Kuldeep Singh Is Compliance Testing of IEC 60601-2-63 mandatory for Europe - Dental X-Ray machine CE Marking (Conformité Européene) / CB Scheme 3
N IATF 16949 - Mandatory Corporate Documents IATF 16949 - Automotive Quality Systems Standard 10
S Are Defibrillator Protection and Pacemaker pulse detection features mandatory as per IEC 60601-2-25 or 2-27...? IEC 60601 - Medical Electrical Equipment Safety Standards Series 11
C ISO 7010 m002 mandatory action - Color requirements on Packaging IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
K Is Defib Protection mandatory for wearable ECG? IEC 60601 - Medical Electrical Equipment Safety Standards Series 10
U Whether First Article Inspection Report- FAI is mandatory for regular Human Factors and Ergonomics in Engineering 4
Sidney Vianna IAF Mandatory Document #23 - Control of CB Franchisees and Agents Registrars and Notified Bodies 3
Marc IAF Mandatory Documents (MD Series) - Required to be used by certification bodies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
A Policies Mandatory or essential for ISO 27001 implementation IEC 27001 - Information Security Management Systems (ISMS) 6
S Is it mandatory for a Calibration Lab to be ISO 17025 accredited? General Measurement Device and Calibration Topics 7
SATHYABALARAMAN IATF 16949 2016 Mandatory procedure IATF 16949 - Automotive Quality Systems Standard 2
SATHYABALARAMAN IATF 16949 2016 Mandatory procedure Imported Legacy Blogs 0
T EASA P 145: What mandatory information should on the purchase order of the customer ? EASA and JAA Aviation Standards and Requirements 2
F Is IEC 60601-1-11 recommended or mandatory for devices manufactured after June 2013? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
J Are Product Special Characteristic(s) Mandatory? IATF 16949 - Automotive Quality Systems Standard 4
Marc IAF (international accreditation forum) - Mandatory Documents (MD Series) ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 0
S Is it mandatory to provide the results of the validation report in handwriting? ISO 13485:2016 - Medical Device Quality Management Systems 5
A Type of evidence for Mandatory procedures 4.4.2 A ad 8.5.1 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Richard Regalado ISO/IEC 27001 Mandatory Documentation Checklist IEC 27001 - Information Security Management Systems (ISMS) 1
K Mandatory Electrical Safety Tests - Regular Production Line IEC 60601 - Medical Electrical Equipment Safety Standards Series 9
R Is there a mandatory medical device warehouse standard for europe? EU Medical Device Regulations 3
J Draft Guidance document compliance mandatory to avoid a RTA? Other US Medical Device Regulations 2
G Is it mandatory to record all processes in form 2 of AS9102 FAI report AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
A Is it mandatory to revise MSDS every three years? ISO 14001:2015 Specific Discussions 3
N Is IEC 62353 Mandatory for Medical Devices? IEC 60601 - Medical Electrical Equipment Safety Standards Series 11
T ISO 9001:2008 Mandatory Procedures in Quality Manual ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
E Is cGMP Training Mandatory? US Food and Drug Administration (FDA) 12
J Can the mandatory procedures of ISO 9001-2008 be documented within one procedure? Document Control Systems, Procedures, Forms and Templates 5
D FDA required (mandatory) Signed Records Qualification and Validation (including 21 CFR Part 11) 1
T Is the use of Control Charts Mandatory or Optional? ISO 17025 Requirements ISO 17025 related Discussions 6
M Are there any Mandatory Processes required in ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
P Mandatory wording of Intended Use Other US Medical Device Regulations 2
M Quality Manual - ISO 17025 required Mandatory and Operational Procedures ISO 17025 related Discussions 7
F ISO/CD 9001:2015 - The 6 mandatory requirement (procedures) are extend to 9 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
X Are defined roles and responsibilities mandatory for ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2

Similar threads

Top Bottom