SBS - The best value in QMS software

Addition of a Class 1 (Sterile) Medical Device

J

J1980b

Starting to get Involved
#1
#1
Hello,

Could someone please confirm if I would need to make a submission to my regulatory body to manufacture a Class ! (sterile) device.

The device does fall within one of our Annex V scope product descriptions. It is a new product within this generic grouping (ie different materials, and a few different components)

I am confused as to if I need to make a formal submission to them and at what level, as technically its not an addition to scope.

Thanks in advance

J1980b
 
Standard Work Instruction Software by Dozuki
Elsmar Forum Sponsor
GStough

GStough

Staff member
Super Moderator
#3
#3
J1980b said:
Hello,

Could someone please confirm if I would need to make a submission to my regulatory body to manufacture a Class ! (sterile) device.

The device does fall within one of our Annex V scope product descriptions. It is a new product within this generic grouping (ie different materials, and a few different components)

I am confused as to if I need to make a formal submission to them and at what level, as technically its not an addition to scope.

Thanks in advance

J1980b
Click to expand...
There are stringent requirements that pertain to sterile medical devices not only here in the US, but in the EU, as well. I believe it would be wise to ask your regulatory body at least, because while it may not be an addition to scope, it would involve an additional process (sterilization) which would require validation and monitoring (especially if it is an outsourced process).

I could be wrong about this, but I think it would be wise to contact your regulatory body (or maybe registrar or notified body, etc.).

I hope this helps some, anyway... :bigwave:
 
chris1price

chris1price

Trusted Information Resource
#4
#4
Hi

Assuming there is no change in the manufacturing processes that would effect sterilisation or changes to the sterilisation process itself and the scope of your CE Certificate does not require modifying, your Notified Body should have little interest in this change.

However, I would still contact them in writing, saying what you are doing and explaining that there are no significant changes that effect them. That way there should be no surprises when it comes to your next scheduled audit.

Chris
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
dgrainger New decision by MHRA on disclaimers - addition of "manner of use as perceived by the consumer" UK Medical Device Regulations 1
O In addition to the standard, what other ISO 13485 sources do people recommend? ISO 13485:2016 - Medical Device Quality Management Systems 5
shrutisancheti Addition of flat panel detector EU Medical Device Regulations 1
I Importer Address in addition to Manufacturer details on label EU Medical Device Regulations 13
S Is Lot Number required in addition to UDI serial number? Other Medical Device Regulations World-Wide 7
C Addition of Design & Manufacture - CE Mark Reissue? EU Medical Device Regulations 1
K Addition of a test reader to existing CE marked product. Other ISO and International Standards and European Regulations 2
M CO2 Incubators - Equipment Qualifications in addition to Calibration Qualification and Validation (including 21 CFR Part 11) 5
Q Actions Taken - Updating a FMEA for the addition of a downstream poke yoke FMEA and Control Plans 3
E Addition of Label by Initial Importer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S Addition in the Scope of Quality Manual ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
S Is TGA approval required for a ARTG listed IVD for a sample type addition? Other Medical Device Regulations World-Wide 11
WCHorn Informational How the addition of "Risk" will affect ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 103
G Document Control - Are hard copies required in addition to soft copies maintained? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
S MDD Technical File CE Mark - Addition of a Device to our Current CE Marked Family EU Medical Device Regulations 4
D Packaging Addition - Non-sterile barrier to protect the whole package 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 12
P Addition of Testing to Our ISO 17025 Scope - How? ISO 17025 related Discussions 1
E Addition of French Language (translation) - New 510(k) required? Other US Medical Device Regulations 1
somashekar ISO 13485 & ISO 9001 certified with addition of site. Covegratulations 10
N AS9100 Certification in addition to TS-16949 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
L CEDAC (Cause and Effect with Addition of Cards) - Sharing Experiences and Form(s) Training - Internal, External, Online and Distance Learning 15
K Differences - ISO17025:1999 vs. ISO17025:2005 - The addition of "Improvement" in 4.10 ISO 17025 related Discussions 16
S Value addition to product ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
A Validation of Processes in addition to Customer Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
J Differences - ISO 13485 - Requirements in Addition to ISO 9001:2000 ISO 13485:2016 - Medical Device Quality Management Systems 25
C Is it necessary to have a documented 3 R recycling plan in addition to measures? Miscellaneous Environmental Standards and EMS Related Discussions 10
L Class IIb devices marked EC according to the 93/42/CE - Portugal CE Marking (Conformité Européene) / CB Scheme 3
J Biocompatbility testing on Class 1 device requirements Other US Medical Device Regulations 12
J Reusable surgical Instrument is under class IIa? EU Medical Device Regulations 3
H EU CE marking for Medical Device Class I EU Medical Device Regulations 0
E Any sample of a full software life cycle IEC 62304 report ( any class )? IEC 62304 - Medical Device Software Life Cycle Processes 1
JoCam Certified QMS for MDR - Class I medical device manufacturers EU Medical Device Regulations 4
N Is there a need for clinical test of Class IIa products (for MDR)? EU Medical Device Regulations 2
K CE Marking Class 1 (Non sterile) medical device CE Marking (Conformité Européene) / CB Scheme 3
G Voluntary Class I Device Filing Other US Medical Device Regulations 4
J IEC 60601-1-11 Home Class II With Ballasts IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
A ISO 13485 for Class 1 Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 7
N Validating Software before getting approved as Class 2 device US Food and Drug Administration (FDA) 5
D Can a diagnostic device be class I? EU Medical Device Regulations 1
A AMSQQP416E Class 2 type 2 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
S IVD risk class II devices for Brazil and MDSAP Other Medical Device Regulations World-Wide 0
P Anyone have an Idea on UAE Medical device registeration- Class B with FDA only Other Medical Device Regulations World-Wide 0
F Mobile app regulations - Class II medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Medical watch Class II (AP Type CF) with USB connection IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
L Radiology software Class I exemption Medical Device and FDA Regulations and Standards News 3
K CE Marking for Class I Medical Device? CE Marking (Conformité Européene) / CB Scheme 7
A Class I (exempt) testing requirements Other Medical Device Related Standards 0
Z Class I marketing regulation and supply chain Other Medical Device Regulations World-Wide 0
S We are looking for EU authorised Representative for both Class I and Class IIb devices EU Medical Device Regulations 7
S How is the service life for class I reusable medical devices described in MDR? EU Medical Device Regulations 7

Similar threads

Top Bottom