The meaning of MDR Article 61 6(b)

#1
Hello everyone,

Article 61 6(b) of the MDR defines in some implants are exempted from the clinical investigations list, such as dental braces, wires, etc.

The original text is as follows:

6. The requirement to perform clinical investigations pursuant to paragraph 4 shall not apply to implantable devices
and class III devices:
(b) that are sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips or
connectors for which the clinical evaluation is based on sufficient clinical data and is in compliance with the relevant
product-specific CS, where such a CS is available.

Since these products such as dental braces do not meet the definition of implants in Article 2(5) ‘implantable device’, whether this exempted list is not limited to " implantable devices"? Or I misunderstood the classification of products such as braces?
 
Elsmar Forum Sponsor
#2
Hello,

Our notified body's interpretation of the definition is, that dental braces are implantable devices. They argument, that an orthodontic intervention is a clinical intervention and dental braces remain in place for more than 30 days.
 
Thread starter Similar threads Forum Replies Date
S Meaning of Article 61 (10) of the MDR 2017/745 EU Medical Device Regulations 3
A What's the meaning of the modified device? EU Medical Device Regulations 0
D The meaning of the term CAPA ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
A Article 54, Article 61(4) the meaning of marketed device EU Medical Device Regulations 8
Watchcat FDA will not tolerate fraud…meaning what, exactly? Other US Medical Device Regulations 7
QIE FDA 21 CFR Part 11 "Meaning of Signature" Other US Medical Device Regulations 6
Mikishots Definition Defined - Definition and meaning of "defined" Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 10
H Meaning of Annex II, excluding point Clause 4 conformity CE Marking (Conformité Européene) / CB Scheme 4
T Supplier monitoring - The meaning of "8.4.2.4 " Customer disruptions IATF 16949 - Automotive Quality Systems Standard 1
E SPC for Dummies - The correct meaning of all the graphs Statistical Analysis Tools, Techniques and SPC 3
E Definition Integrity - The meaning of the word INTEGRITY in ISO 13485 Control of Records Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 6
E Definition QUALITY 4.0 - Somebody here could explain the meaning of Quality 4.0? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 2
F EU Definition of Labeling or the meaning of the MDD (Medical Devices) EU Medical Device Regulations 7
N What is the meaning of Suspended in OASIS? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
M OEE - The meaning of the single number Quality Tools, Improvement and Analysis 12
C Meaning of "direct diagnosis" (Annex IX, Rule 10) EU Medical Device Regulations 6
G What is the exact meaning of Single Fault condition? EU Medical Device Regulations 4
S ECR - meaning of "Control Item Affected: Yes or no" IATF 16949 - Automotive Quality Systems Standard 1
Ajit Basrur Do you know the meaning of these words ??? Coffee Break and Water Cooler Discussions 4
W UL standard for Lead wire - meaning of UL numbering, AWG#, no. of conductor, etc Various Other Specifications, Standards, and related Requirements 1
N Agile 9.3.1 Relationship Searches - Meaning of Message Manufacturing and Related Processes 1
S Scenario to illustrate the meaning of CAPA Nonconformance and Corrective Action 7
E AS9100 Section 7.6 - What is the meaning of "check method"? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
B AS 9100C sec 8.2.4 - " Recognized Statistical Principles" meaning AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
M 7.6.2 Revisions following Engineering Changes - What is the right meaning? IATF 16949 - Automotive Quality Systems Standard 4
S Surface Profile of a Hole - The meaning of the tolerance in the provided drawing Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
M ISO 9001 - 7.5.5 - Meaning of Identification and how it helps Product Preservation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Stijloor The meaning of "Gibby." Coffee Break and Water Cooler Discussions 10
I ERP acronym has double meaning in our company Internal Auditing 6
M Suitability and Meaning of PED (Pre-Established Dispositions) to Quality Objectives IATF 16949 - Automotive Quality Systems Standard 2
A What's meaning of T series for a bolt or nut? Supplier Quality Assurance and other Supplier Issues 3
J Definition Performance - The Meaning of Performance in TS 16949 Clause 7.4.3.1 Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 7
kedarg6500 What is the meaning of "define/defined" in ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
M Design and Development: What is the right meaning? IATF 16949 - Automotive Quality Systems Standard 6
J What is the meaning of "Repair" as in TS 16949 Clause 6.4.2? IATF 16949 - Automotive Quality Systems Standard 3
J ISO 14155:2011 - The meaning of the term "Should" EU Medical Device Regulations 8
M The Statistical Meaning of "Muddy Middle" - Statistics Terminology Statistical Analysis Tools, Techniques and SPC 6
R What is the meaning of "Highest RATED Current" in Protective Earth Impedance Test? IEC 60601 - Medical Electrical Equipment Safety Standards Series 8
S What's the meaning of "Quality Management System Requirements" in 7.4.2 (c)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
J Meaning of Business Management System in IRIS (International Rail Industry Standard)? Various Other Specifications, Standards, and related Requirements 4
S What's the meaning of 'methods' in 4.1(c) ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
S Meaning of n-1 in Standard Deviation Quality Tools, Improvement and Analysis 12
H What's the meaning of this paragraph from AS9100B: 'Page31----7.6 f)? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
H What's the meaning of "a minimum 95% reliability target"? General Measurement Device and Calibration Topics 14
Q Definition FRACAS - What is the meaning of FRACAS Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 2
J What's the meaning of word "map" (Map these requirements with your implemented QMS)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 22
K Definition Correlation - The meaning of correlation and and its application in data analysis Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 4
P What is the meaning of your Elsmar Cove Forum User Name? Coffee Break and Water Cooler Discussions 58
B Definition Competence - What is the meaning of Competence? ISO 9001 Clause 6.2.2 Competence Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 13
P 8.2.3.1 - What is the meaning of this text? IATF 16949 - Automotive Quality Systems Standard 10

Similar threads

Top Bottom