Packaging as Medical Device (temperature sensitive products)

V

Vitora

#1
Dear colleagues,

I have a question regarding packaging solutions for vaccines / blood transportation (temperature sensitive products).

Could this packaging be considered as Class I Medical Device?

I have found by google'ing some information about Insulated packaging standards, regulation for the transport of infectious substances, etc., but nothing regardless being a medical device.

I will appreciate any help or guidance.

:eek:
 
Elsmar Forum Sponsor

pkost

Trusted Information Resource
#2
Re: Packaging as Medical Device...

I will assume you are refering to EU regs:

I do not believe they would be considered medical devices under the current directive,

I cannot say for certain but the vaccines are more likely to be covered in some way by medicinal product regulations. The blood will likely be covered by the following directives: 2002/98/EC and 2004/33/EC
 
#3
Re: Packaging as Medical Device...

Not sure if this necesarily applies but classification rule 2 states:-
All non-invasive devices intended for channelling or storing blood, body
liquids or tissues, liquids or gases for the purpose of eventual infusion,
administration or introduction into the body are in Class IIa
And Rule 18:-
By derogation from other rules, blood bags are in Class IIb
And then from the Borderline Classification Manual:-
http://www.google.co.uk/url?sa=t&rc..._ID4Bw&usg=AFQjCNFEkCtCjcvFsUV1Nel7HpfCivPVjg
The physical containers for the transport of organs are regulated as medical devices and are given as an example in MEDDEV 2.4/1 under classification rule 2, second indent ?devices intended for temporary storage and transport of organs for transplantation? and ?devices intended for the long term storage of biological substances and tissues such as corneas, sperm, human embryos etc?.
But I think that in each of these cases it is referring only to the primary container (say - the test tube) and not to an insulated box that is used to keep it cool in transport. But if critical temperatures must be maintained you will need to validate your chosen packaging.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Re: Packaging as Medical Device...

Hi,

If a blood bag's labeling, for instance, says that this bag needs to be put inside a heat insulating enclosure (or similar), in order to fulfil its intended use (=blood storage etc.), then an insulating enclosure intended for such use may be considered in the EC an Accessory to that blood bag, and hence be regulated just like a medical device under the MDD.

Cheers,
Ronen.
 
M

MIREGMGR

#5
Re: Packaging as Medical Device...

If a blood bag's labeling, for instance, says that this bag needs to be put inside a heat insulating enclosure (or similar), in order to fulfil its intended use (=blood storage etc.), then an insulating enclosure intended for such use may be considered in the EC an Accessory to that blood bag, and hence be regulated just like a medical device under the MDD.
Seems to me as if this is a gray area at best. A "heat insulating enclosure" doesn't seem to me to be especially conceptually different from a sterile-barrier pouch, which in my experience is considered to be packaging, not a device or accessory.

ISO 11607-1 and -2 uniformly assume that packaging is packaging, not a device or accessory.
 

Ronen E

Problem Solver
Staff member
Moderator
#6
Re: Packaging as Medical Device...

Seems to me as if this is a gray area at best. A "heat insulating enclosure" doesn't seem to me to be especially conceptually different from a sterile-barrier pouch, which in my experience is considered to be packaging, not a device or accessory.

ISO 11607-1 and -2 uniformly assume that packaging is packaging, not a device or accessory.
This is why I wrote "may be considered" and not "is considered". My intention was to draw attention to that aspect.

If the EC Accessory definition was strictly applied, sterile barriers were ought to be considered Accessories. Good thing they in fact don't, but from a theoretical analysis standpoint it doesn't necessarily say too much.
 
V

Vitora

#7
Re: Packaging as Medical Device...

Not sure if this necesarily applies but classification rule 2 states:-


And Rule 18:-


But I think that in each of these cases it is referring only to the primary container (say - the test tube) and not to an insulated box that is used to keep it cool in transport. But if critical temperatures must be maintained you will need to validate your chosen packaging.
Thank you for your answer.
I was thinking that rule 2 aplies the best (as for non-invasive devices).
Rule 18 - does not, as I did not mean blood bags themselth, but these packaging might be use for blood transportation already IN blood bags.
Anyway consultation with Regulatory Body would be beneficial.
:thanx:
 
Thread starter Similar threads Forum Replies Date
A FDA guidance on non-sterile Medical Device Packaging Medical Device and FDA Regulations and Standards News 7
M MDR - Packaging - Secondary Medical Device Boxes EU Medical Device Regulations 2
B 510(k) clearance claim on medical device product packaging Other US Medical Device Regulations 6
T Colour of symbols on Medical Device labelling and packaging Other Medical Device Related Standards 1
I Medical Device Packaging Multilingual Labeling EU Medical Device Regulations 3
shimonv GTIN Number on the Packaging of a Serviced Medical Device EU Medical Device Regulations 0
shimonv Is UDI required on the Packaging of a Serviced/Repaired Medical Device? Other US Medical Device Regulations 3
C QR Code on Medical Device Packaging and Notification to Notified Body EU Medical Device Regulations 1
TheMightyWife Address Change - Medical Device Packaging Labelling Requirements EU Medical Device Regulations 7
V Tyvek packaging for Medical device process validation Qualification and Validation (including 21 CFR Part 11) 2
A Medical Device Class 2A, non sterile bodyworn packaging requirements CE Marking (Conformité Européene) / CB Scheme 7
N Medical device non sterile packaging requirement CE Marking (Conformité Européene) / CB Scheme 1
P Secondary packaging operations in medical device facility Manufacturing and Related Processes 1
C Medical Device Packaging Manufacturing - How should product be stored on the pallet 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
R Medical Device Packaging Label Validation Other US Medical Device Regulations 8
ScottK Importing medical device for use in fit testing of packaging Other US Medical Device Regulations 3
S Three Questions on Finished Medical Device Traceability, Labeling and Packaging US Food and Drug Administration (FDA) 3
R Regulatory Aspects of Co-Packaging Medical Device and Cosmetic Other Medical Device and Orthopedic Related Topics 6
Q FDA Medical Device Accessory Packaging Requirements US Food and Drug Administration (FDA) 12
J Packaging and User Manual for Medical Device and Accessory CE Marking (Conformité Européene) / CB Scheme 3
N Symbol for Medical Device Sterile Packaging - "Inspect Seal Before Opening" Other Medical Device Related Standards 5
J Labeling Software for Medical Device Product and Packaging Labels for Production Use Other Medical Device Regulations World-Wide 5
J Latex Adhesive Labels used in Medical Device Packaging Other US Medical Device Regulations 7
K Customer Notification Requirements - New Packaging Machine for Class 1 Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 1
J Translation Requirements on Medical Device Packaging Labels ISO 13485:2016 - Medical Device Quality Management Systems 5
E Reference Standard for Shelf Life Testing of Packaging for Sterilized Medical Device Other US Medical Device Regulations 3
P Environmental Control for Storage of Medical Device Packaging Material Other Medical Device Related Standards 8
N Medical Device Secondary Packaging Facility - Regulatory Compliance Requirements? EU Medical Device Regulations 2
ScottK MDD (Medical Device Directive) and Secondary Packaging EU Medical Device Regulations 3
P Reference Material for Medical Device Cleaning and Packaging Manufacturing and Related Processes 1
M Odd Contract Medical Device Manufacturing Situation - Medical Device Packaging 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
S Sterile Product Ship Testing (Medical Device Packaging) EU Medical Device Regulations 3
D Medical Device Packaging - Trying to learn Technical files EU Medical Device Regulations 4
E "Sales Packaging" contents - Medical Device company Other ISO and International Standards and European Regulations 1
M Checklist for ISO 11607-2:2006 - Medical Device Packaging - Information needed Other Medical Device Related Standards 9
P Is there a requirement for country of origin on packaging of class 2a medical device? Other Medical Device and Orthopedic Related Topics 17
S Relevant Packaging Standards for Medical Device Package testing ISO 13485:2016 - Medical Device Quality Management Systems 10
S Packaging Instruction and BOM Control - Manufacturer of a medical device Document Control Systems, Procedures, Forms and Templates 11
L Packaging unsterile medical devices ISO 13485:2016 - Medical Device Quality Management Systems 6
Y Packaging validation for non-sterile Medical Equipment Other Medical Device Related Standards 1
M List of Packaging Contents - Medical Devices - Interpreting EU Directive 93/42/EEC CE Marking (Conformité Européene) / CB Scheme 3
J Canada Bulk Packaging and IFU requirements for Class IIa and IIb Medical Devices Canada Medical Device Regulations 2
S Medical Implant Sterile Packaging Design EU Medical Device Regulations 6
P Sterile Medical Packaging and Shelf Life Validation Sample size ISO 13485:2016 - Medical Device Quality Management Systems 10
J SFDA Finalizes its Rules on Packaging and Labeling of Imported Medical Devices China Medical Device Regulations 0
C Class I Medical Devices - Country of Origin Marking on Retail Packaging (Labeling) Other US Medical Device Regulations 4
A CE Marking and Packaging Requirements for Class I Sterilized Medical Devices EU Medical Device Regulations 8
M Packaging Requirements for Non-Sterile Class II Medical Devices EU Medical Device Regulations 11
T Packaging Subcontractor Certification - Class I and Class II Medical Devices Supplier Quality Assurance and other Supplier Issues 2
J Shelf Life Validation for new Heat Impulse Medical Packaging Sealer Qualification and Validation (including 21 CFR Part 11) 2

Similar threads

Top Bottom