Classification under MDR

#1
Hi All,

One of the materials of medical devices is hyaluronic acid which comes from streptococcal fermentation.
Does the hyaluronic acid apply to rule 18 of the classification requirements of MDR?

Rule 18
All devices manufactured utilising tissues or cells of human or animal origin, or their derivatives, which are non- viable or rendered non-viable, are classified as class III, unless such devices are manufactured utilising tissues or cells of animal origin, or their derivatives, which are non-viable or rendered non-viable and are devices intended to come into contact with intact skin only.

Thank you in advance for your explanation
 
Elsmar Forum Sponsor

Raisin picker

Involved In Discussions
#2
As far as I know, bacteria are not considered animals ;-). Manufacturers who used to produce the HA from rooster combs are now switching to the fermented variety exactly for that reason.
But, just to be sure, ask your NB as soon as possible.
 
Thread starter Similar threads Forum Replies Date
K Biological indicator system classification under MDR EU Medical Device Regulations 2
N Medical Device Classification under MDR - Rule 21 EU Medical Device Regulations 11
E Wristwatch Skin-proximal glucose sensor - Classification under MDR EU Medical Device Regulations 4
C Substance based Medical Device Classification under MDR - Rule 21 EU Medical Device Regulations 9
somashekar Advice on Device classification under MDD Annex IX. EU Medical Device Regulations 8
C How about the classification under 93/42/EEC? Sterile oxygen mask ISO 13485:2016 - Medical Device Quality Management Systems 7
A IEC 62304 safety classification, External Controls and off-label use related risks IEC 62304 - Medical Device Software Life Cycle Processes 5
R Classification of USB DC operated medical equipment IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
D Surgical Instrument Tray Classification EU Medical Device Regulations 5
S Classification of a product according to MDR EU Medical Device Regulations 3
shimonv Classification of a cloud- base viewer for the output from a medical device US Food and Drug Administration (FDA) 7
A FDA Class Classification for a cabinet 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
dinaroxentool Question about FDA Classification of a Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
N What is our product classification? (Does Unclassified classification still exists) Other US Medical Device Regulations 14
nadhar2 Classification of Action Items Misc. Quality Assurance and Business Systems Related Topics 3
A Class medical device (MDD) - Classification help EU Medical Device Regulations 1
D IEC 62304 Risk Classification - With and without hardware control IEC 62304 - Medical Device Software Life Cycle Processes 2
M Classification of Clean Rooms Other Medical Device Related Standards 9
A ISO 10993-7:2008/ Amd.1:2019 - Classification of special populations Other Medical Device Related Standards 3
DuncanGibbons Classification of aerospace parts depending on their risk and criticality etc. Federal Aviation Administration (FAA) Standards and Requirements 3
M Barrier cream classification EU Medical Device Regulations 2
M Risk Classification For Supplier - Clinical Research Organisation (CRO) Supply Chain Security Management Systems 3
D Classification of Syringe (nozzle) of needle free injection system. EU Medical Device Regulations 8
S CE Mark - Classification Confusion EU Medical Device Regulations 12
S Medical Device Product Classification in South Korea Other Medical Device Regulations World-Wide 1
M Informational US FDA – Ear, Nose, and Throat Devices; Classification of the Self-Fitting Air-Conduction Hearing Aid Medical Device and FDA Regulations and Standards News 0
D MDR 2017/745 Classification Guide EU Medical Device Regulations 8
M Informational EU – Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR Medical Device and FDA Regulations and Standards News 2
dgrainger Informational MDCG 2019-11: Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR Medical Device and FDA Regulations and Standards News 0
M Informational EU MDR Classification Rule 11 – what??? Medical Device and FDA Regulations and Standards News 9
M Informational US FDA Final Guidance – Acceptance Review for De Novo Classification Requests Medical Device and FDA Regulations and Standards News 1
A Fire hazard classification - Clause in IEC 60601 about gauze and electricity ISO 14971 - Medical Device Risk Management 0
J MDR Annex VIII, Rule 6 Classification - Implication for lower risk CV products? CE Marking (Conformité Européene) / CB Scheme 3
A Device Classification - India CDCSO - How to classify the device? Other Medical Device Related Standards 1
B ASTM F2924-14 /ASTM F3001 - Room temperature classification criteria Other US Medical Device Regulations 0
M Informational EU – MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES Version 1.22 (05-2019) Medical Device and FDA Regulations and Standards News 2
K MEDDEV 2.4/1 rev. 9 Classification EU Medical Device Regulations 1
M Informational USFDA – Medical Devices; Anesthesiology Devices; Classification of the Ventilatory Electrical Impedance Tomograph Medical Device and FDA Regulations and Standards News 0
N Medical Device Re-Classification EU Medical Device Regulations 2
B Class IIB Device - IEC 62304 Software Classification IEC 62304 - Medical Device Software Life Cycle Processes 13
C Suppliers re-classification from Critical to Significant or from Significant to Non-critical Supply Chain Security Management Systems 0
J Medical Device re-classification and marketing ISO 13485:2016 - Medical Device Quality Management Systems 13
M APQC PCF (Process Classification Framework) and ISO 9001 - Processes Based Approach ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Informational TGA – Several proposed changes to classification to better align with the EU MDR Medical Device and FDA Regulations and Standards News 0
N Medical Device Accessory Classification - Software as a Medical Device Other Medical Device Regulations World-Wide 5
G EU MDR 2017/745 Rule 11 interpretation - Re-classification of a Software as Medical Device Other Medical Device Related Standards 0
M Medical Device News Manual On Borderline And Classification In The Community Regulatory Framework For Medical Devices Medical Device and FDA Regulations and Standards News 0
M FDA News USFDA Final Rule – Medical Device Classification Procedures: Incorporating Food and Drug Administration Safety and Innovation Act Procedures Medical Device and FDA Regulations and Standards News 0
M FDA News The FDA Issues Final Rule on Medical Device Classification Procedures Medical Device and FDA Regulations and Standards News 0
K Biocompatibility classification for Lancet CE Marking (Conformité Européene) / CB Scheme 7

Similar threads

Top Bottom