SBS - The best value in QMS software

Medical Devices CLP Regulation

Brian Benzarti

Brian Benzarti

Registered
#1
#1
Where to find specific requirements and rules stating when a product CLP review is recommanded or necessary!?

Noting that, a Safety Data Sheet "Section 2 - Hazards Identification/CLP" depends principally on all CLPs of individual components formulating the finished product.
Hence, further to any change/update of one component CLP, it's mandatory to accordingly update the SDS/CLP of the finished product(s).
However, in case of multiple finished products, where the same component is used, shall we update all finished products CLPs/SDS!? This is really time and money consuming! Moreover, this must be done by Expert Toxicologist .... consultation..!!
So looking for assistance, if perhaps we can define internal process of review or maybe periodically ... ; for example review each 2 or 3years of all Products CLPs!
Otherwise, it won't be easy to assess the impact of a component CLP change on the CLP of the finished product CLP, without a full review.

Kindly assist! thanks!
 
Last edited:
Standard Work Instruction Software by Dozuki
Elsmar Forum Sponsor
planB

planB

Super Moderator
#2
#2
Brian,

in case you are referring to Regulation (EC) No 1272/2008 on the classification, labelling and packaging of substances and mixtures (CLP Regulation): no there is no specific requirement for medical devices that you have to perform the kind of review you are describing above.

What you do have to do is to demonstrate that the device is biocompatible for its intended use, and maintain its biological safety as long as you put the device on the market. In this context a periodic SDS review may or may not support this activity, since there is no direct link between SDS information and biocompatibility: SDS have mainly been developed in the context of occupational safety, i.e. help the user of chemicals and mixtures to not get harmed or harm others (including the environment) when handling the affect substance (mixture).

Another possible approach: define in your supplier contract that your suppliers have to notify you in case the SDS changes in content.

Have also a look into (EC) No 745/2017 (MDR, Medical Device Regulation), Annex I, chapter II, section 10.4 about substance requirements specific for medical devices.

Hope this helps,
 
Brian Benzarti

Brian Benzarti

Registered
#3
#3
Hi B,

Thanks a lot for assistence!

Yes you're right, biocompatibility work is in progress as a main task that must be achieved as you mentioned!

In your above clarification, yes you raiseded up the most important point "to define in the SQA Supplier Quality Agreement", the supplier must inform us in case if any changes in CLP contexts, afterwards an internal process for review can be drafted with a specified coverage interval.
Otherwise, it won't be easy to have a full control, the process is here the important point. We should also keep attention that CLP texts as a basis of SDSs review, should be also printed on products Printed Matters (Box, Instruction, ..).

:bighug:
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
T Google Fit Health datas and Medical devices Application Medical Information Technology, Medical Software and Health Informatics 0
B Procedure packs with non-medical devices EU Medical Device Regulations 1
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
A Customer Approval (Medical Devices) Document Control Systems, Procedures, Forms and Templates 4
D Electrical Medical Devices class I EU Medical Device Regulations 0
J Are complaints applicable to development of medical devices? Customer Complaints 2
P Do we need to retrospectively use the "MD" symbol (indicating device is a medical device) on labels, e.g. finished devices within expiration date? EU Medical Device Regulations 2
dgrainger Informational Medicines and Medical Devices Act 2021 UK Medical Device Regulations 0
A Sampling plan for in-process QC (medical devices) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 13
B Free Sales Certificate for Non Medical Devices Other Medical Device Related Standards 2
K Usability for custom made medical devices IEC 62366 - Medical Device Usability Engineering 5
dgrainger Informational MHRA - Regulating medical devices in the UK - Post Brexit - 2021-02 UK Medical Device Regulations 0
M Europe GMP medical devices - Combination products - Ancillary medicinal substance CE Marking (Conformité Européene) / CB Scheme 4
L Shelf life of medical devices Other Medical Device Related Standards 4
M Medical Devices - Ancillary - ISO 10993-17 Medical Device and FDA Regulations and Standards News 6
S How is the service life for class I reusable medical devices described in MDR? EU Medical Device Regulations 7
S How is the service life described for class I reusable medical devices in MDR? Elsmar Xenforo Forum Software Instructions and Help 1
M Brexit The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 UK Medical Device Regulations 1
P New Global HQ Suggestions for Virtual manufacturing/own brand labelling of medical devices? EU Medical Device Regulations 4
N Chemical Testing on Medical Devices - Solutions in a container closure system (bag) EU Medical Device Regulations 1
M Is IEC 60601-1-2 required by FDA for all electronic medical devices? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M Subcontracting a repair of Medical Devices Canada Medical Device Regulations 0
S Regrind Material in Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 1
R Product Recall - medical devices in the hospital warehouse Canada Medical Device Regulations 2
P Monolithic application and medical devices ISO 13485:2016 - Medical Device Quality Management Systems 2
N Medical Devices in oxygen rich environment IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
M Medical Devices Shelf Life ---INDIA Other Medical Device Regulations World-Wide 3
JoCam Warranty of Medical Devices EU Medical Device Regulations 2
R Obsolesce medical devices ISO 13485:2016 - Medical Device Quality Management Systems 1
dgrainger Informational UK - Medicines and Medical Devices Bill 2019-21 UK Medical Device Regulations 0
S Call it refurbish or not? Medical Devices Manufacturing and Related Processes 2
C Registering Medical Devices in Australia and New Zealand - ANZTPA Other Medical Device Regulations World-Wide 0
S Requirements for "Claims Guide" for medical devices Medical Device and FDA Regulations and Standards News 6
C FDA Establishment registration - Buying some medical devices from another manufacturer Medical Device and FDA Regulations and Standards News 5
G Accelerated stability of medical devices Other Medical Device Related Standards 1
A Medical Device Vigilance decision tree for Japan for class 2 devices. Japan Medical Device Regulations 1
K Contamination Control - Class Is medical devices (Clause 6.4.2 ISO 13485:2016 (E)) ISO 13485:2016 - Medical Device Quality Management Systems 12
W Seeking Guidance Verification Test Strategy for Class B Medical Devices IEC 62304 - Medical Device Software Life Cycle Processes 1
G Free Sales certificates for Medical Devices - List of countries EU Medical Device Regulations 4
dgrainger Informational Parliament to vote on postponing new requirements for medical devices -17th April Medical Device and FDA Regulations and Standards News 1
K Old medical devices -> 7.3.7. Design and development validation ISO 13485:2016 - Medical Device Quality Management Systems 1
M Who needs a MDEL? How to buy and sell medical devices on my own Canada Medical Device Regulations 14
D Social Media Feedback process for Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 6
M Post Market Surveillance for Class II Medical Devices Medical Device and FDA Regulations and Standards News 2
M Special Controls and Class II Medical Devices Medical Device and FDA Regulations and Standards News 18
dgrainger Informational Have your say on the UK's Medicines and Medical Devices Bill Medical Device and FDA Regulations and Standards News 0
L Packaging unsterile medical devices ISO 13485:2016 - Medical Device Quality Management Systems 6
R Expected life span of Medical devices - X-Ray based diagnostic medical devices ISO 13485:2016 - Medical Device Quality Management Systems 6
Marc Medical device vulnerability highlights problem of third-party code in IoT devices Other Medical Device and Orthopedic Related Topics 1
J UK Medicines and Medical Devices Bill - 2019 ISO 13485:2016 - Medical Device Quality Management Systems 0

Similar threads

Top Bottom