Conformity assessment routes in MDR

S

Shaka256

#1
Hi all,
I am very confused with the conformity assessment options in the MDR. Our device is non-medical under MDD but will become medical (class IIb) under new MDR regulation. I've been reading the conformity assessment options for the past 2 days and still can't figure out- what is the difference between annex IX and annexes X-XI? Both require QMS and technical documentation, audit by NB, etc.
 
Elsmar Forum Sponsor

chris1price

Trusted Information Resource
#2
Hi, this isn't simple and I do not yet have a flow-chart I can share. There are two alternatives for a class IIb device

A. Review of technical documentation by NB for each generic group of devices (or every device is implantable) followed by review of the QMS and surveillance audits (Annex IX).

This is typically used for volume production of different type of device and a full QMS is available.


B. Type Examination of Technical documentation and device by NB (Annex X) followed by either Review of Production Quality Assurance (not full QMS) or Product Verification of every product (Annex XI)

The first alternative is for volume production where only the production is under a QMS (ie design is not under quality systems), the second for low volume production of a single device.

(Some Active class IIb devices have an extra step requiring expert consultation)

I hope this makes some sense!
Chris
 
Thread starter Similar threads Forum Replies Date
P Conformity assessment based on a quality management system or production quality assurance EU Medical Device Regulations 3
H Pedicle screw system Conformity Assessment Other Medical Device Related Standards 2
I Management review in conformity assessment standards - Certification Bodies Management Review Meetings and related Processes 6
M Informational US FDA – Frequently Asked Questions (FAQs) About the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Medical Device and FDA Regulations and Standards News 0
M Informational USFDADraft Guidance – Accreditation Scheme for Conformity Assessment (ASCA) Pilot Medical Device and FDA Regulations and Standards News 0
M Informational IMDRF draft document – Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews Medical Device and FDA Regulations and Standards News 0
S Conformity Assessment Route question for Class IIa medical device under MDR EU Medical Device Regulations 3
M Informational TGA – Guidance on Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 2019 Medical Device and FDA Regulations and Standards News 0
chris1price MDR Conformity Assessment for a Class 2a device - Production Quality Assurance EU Medical Device Regulations 2
S EU conformity assessment - Certify to MDD or MDR? EU Medical Device Regulations 3
S Class II Medical Device Conformity Assessment Route according to Annex V only CE Marking (Conformité Européene) / CB Scheme 7
B CISPR 11 - Assessment of Conformity Other Medical Device Related Standards 4
Sam Lazzara Using MDD Annex III + V Conformity Assessment Pathway EU Medical Device Regulations 2
S RoHS Conformity Risk Assessment - Medical Devices RoHS, REACH, ELV, IMDS and Restricted Substances 2
C CE Mark Conformity Assessment Annex II vs. Annex VII+ CE Marking (Conformité Européene) / CB Scheme 10
T Declaration of Conformity acording to the ZLC 3.9 A4 Conformity Assessment EU Medical Device Regulations 5
E Conformity Assessment under Australian Medical Device Regulations Other Medical Device Regulations World-Wide 3
E Conformity Assessment choices for a Contract Manufactured Class IIa Medical Device Other US Medical Device Regulations 1
Z Conformity Assessment Route from the Medical Devices Directive (93/42/EEC) Help EU Medical Device Regulations 6
Sidney Vianna Conformity Assessment - Informative FREE book by ISO & UNIDO ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 2
Sidney Vianna ISO CASCO (Conformity Assessment Committee) e-Newsletter Other ISO and International Standards and European Regulations 0
Ajit Basrur Presentation on Standardization and Conformity Assessment Bodies General Measurement Device and Calibration Topics 1
C CMDCAS (Canadian Medical Devices Conformity Assessment System) for drugs ISO 13485:2016 - Medical Device Quality Management Systems 3
G ISO 13485 IAF Medical Device Conformity Assessment System IAF-MDCAS ISO 13485:2016 - Medical Device Quality Management Systems 10
Q ISO 17011 (Conformity assessment - General requirements..) Internal Audit Tips wanted Internal Auditing 12
S Conformity of 1 batch vs other Statistical Analysis Tools, Techniques and SPC 5
G Dealing with non conformity caused by Supplier Components detected in the production line IATF 16949 - Automotive Quality Systems Standard 14
CharlieUK Informational ADCO MED EU DECLARATION OF CONFORMITY TEMPLATE CE Marking (Conformité Européene) / CB Scheme 0
Aymaneh Traditional 510(k) Declaration of Conformity Other Medical Device Regulations World-Wide 3
S Definition of "worldwide" in view of IATF 16949 and Product conformity IATF 16949 - Automotive Quality Systems Standard 3
R Declaration of conformity as per EU MDR (2017/745) CE Marking (Conformité Européene) / CB Scheme 5
R IVDR CE Mark for Class A products - Declaration of Conformity CE Marking (Conformité Européene) / CB Scheme 2
M Referencing Harmonised Standards in Declarations of Conformity EU Medical Device Regulations 4
S Can we provide training plan as corrective action for IATF 16949 Non conformity? IATF 16949 - Automotive Quality Systems Standard 9
L MDR 745 - EU Declaration of Conformity - Signature Requirements EU Medical Device Regulations 3
A EC declaration of conformity - In the event clients ask for a copy CE Marking (Conformité Européene) / CB Scheme 12
L Content of Declaration of conformity (MDR) EU Medical Device Regulations 1
qualprod Non conformity, do nothing? Employee experiencing "hard times" ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
J COC (Certificate of Conformity) when NOT purchasing medical devices direct from the Manufacturer Other Medical Device Related Standards 2
N Declaration of Conformity for Product from Supplier ISO 13485:2016 - Medical Device Quality Management Systems 6
J Connection between Technical File and Declaration of Conformity CE Marking (Conformité Européene) / CB Scheme 2
I Who is responsible for signing the Declaration of Conformity and what is their liability Imported Legacy Blogs 0
J Medical Devices in Japan - Conformity of QMS to ISO 13485 Japan Medical Device Regulations 1
S Conformity vs. 8130-3 tag creation date Federal Aviation Administration (FAA) Standards and Requirements 1
D Root Cause on Non-Conformity Against Quality Manual Problem Solving, Root Cause Fault and Failure Analysis 9
Q Signatures on C of Cs (Certificate of Conformity) Supplier Quality Assurance and other Supplier Issues 2
D Determining Critical Components for conformity with IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 21
H Meaning of Annex II, excluding point Clause 4 conformity CE Marking (Conformité Européene) / CB Scheme 4
A Certificate of release/certificate of conformity/certificate of compliance Other Medical Device and Orthopedic Related Topics 3
T ER Checklist - Method(s) of conformity EU Medical Device Regulations 1

Similar threads

Top Bottom