Regulatory Aspects of Co-Packaging Medical Device and Cosmetic

#1
Hi,

Is anyone aware of any particular regulatory issues with placing a cosmetic product within the packaging of a medical device? The medical device is available as consumer over the counter so there is no healthcare professional involvement.

The device and cosmetic provide the user with complementary benefits, although they are not dependent upon one another for either to function. The function of one does not impact upon the function of the other.

Thanks
 
Elsmar Forum Sponsor
#4
The device is an NMES device and the cosmetic is a skin cream designed to improve aesthetic appearance of the skin. I'm primarily interested in EU but a US perspective would also be useful.

Thanks
 

Ajit Basrur

Staff member
Admin
#5
Re: Regulatory Aspects of Neuromuscular Stimulation (NMES) System

The device is an NMES device and the cosmetic is a skin cream designed to improve aesthetic appearance of the skin. I'm primarily interested in EU but a US perspective would also be useful.

Thanks
This is a Class II Medical Device under the scope of 21 CFR Part 890.5850 -

Sec. 890.5850 Powered muscle stimulator.

(a)Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.

(b)Classification. Class II (performance standards).
 
#6
Hi Ajit,

I understand the classification of the devices, my question was related to the regulatory implications of packaging a device and cosmetic together.
 

Ronen E

Problem Solver
Staff member
Moderator
#7
The device is an NMES device and the cosmetic is a skin cream designed to improve aesthetic appearance of the skin. I'm primarily interested in EU but a US perspective would also be useful.

Thanks
Hi,

IMO if the medical device and the cosmetic are sold in the same package, under the same labelling, and you make any claims WRT any interaction between them / mutual benefit, then they should be viewed as a single product. If it's just a convenience package (e.g. each has it's own marketing package and they are both put together in a plain carton or a plain transparent plastic bag / shrink wrap), and their (separate) labelling do not refer to each other then it's in a grey-ish area.

For the former case, for the EC, you might want to consult article 12 of the MDD.

Cheers,
Ronen.
 
Thread starter Similar threads Forum Replies Date
C Legal or Regulatory Requirements as identified in our Environmental Aspects ISO 14001:2015 Specific Discussions 9
P What are all the Regulatory Affairs Aspects Various Other Specifications, Standards, and related Requirements 10
optomist1 Informational Training IMDS - Management of Product Chemical Regulatory Compliance RoHS, REACH, ELV, IMDS and Restricted Substances 2
D Worldwide Regulatory Knowledge Other Medical Device Regulations World-Wide 1
JoCam Rental, service & installation - regulatory requirements EU Medical Device Regulations 2
R Regulatory Affairs Certification (RAC) prep - Practice test versus actual exam Professional Certifications and Degrees 0
K Regulatory Affairs Certification (RAC) Exam - November 2020 preparation Professional Certifications and Degrees 0
dgrainger Clue to UK's new regulatory requirements - approval of all devices placed on the market? Other Medical Device Regulations World-Wide 1
A Regulatory requirements for electrical cosmetic appliances US Food and Drug Administration (FDA) 5
Watchcat Best Regulatory Oversight for Off-Shore Device Manufacturing? Other Medical Device Regulations World-Wide 1
S RA (Regulatory Affairs) certification & Online Internship Professional Certifications and Degrees 11
S ISO 13485 Lead Auditor - Debate between our Quality Team and Regulatory Auditor - Internal Auditor Training ISO 13485:2016 - Medical Device Quality Management Systems 17
J Management Representative and PRRC (Person Responsible for Regulatory Compliance) ISO 13485:2016 - Medical Device Quality Management Systems 4
S Regulatory job in pharma vs. medical device US Food and Drug Administration (FDA) 16
S Regulatory job in pharma vs. medical device CE Marking (Conformité Européene) / CB Scheme 0
M Regulatory clearance pathways for surgical masks/N95 respirators Other US Medical Device Regulations 3
N "Placing on the market" & "putting into service"- one time regulatory event or Continual supply event? EU Medical Device Regulations 2
P MDR PRRC (person responsible for regulatory compliance) and personal liability EU Medical Device Regulations 2
Watchcat Year of the Regulatory Watchcat Other US Medical Device Regulations 6
W Updated EU MDR regulatory matrix wanted ISO 13485:2016 - Medical Device Quality Management Systems 43
S SOPs applicable for Regulatory Affairs department Other ISO and International Standards and European Regulations 1
F ISO 13485 8.2.3 Reporting to regulatory authorities: Question regarding a procedure for this clause. ISO 13485:2016 - Medical Device Quality Management Systems 4
Ronen E Legal counselling and Medical Devices Regulatory Affairs Other Medical Device Regulations World-Wide 2
A Help establishing regulatory requirements - Plastic dental cartridge syringe US Food and Drug Administration (FDA) 0
S Regulatory strategy for Third party plugin in a PACS EU Medical Device Regulations 1
S Regulatory Medical Device PMA Plans US Food and Drug Administration (FDA) 2
M Informational TGA – Australian regulatory action on breast implants and breast tissue expanders Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Draft Guidance – Providing Regulatory Submissions for Medical Devices in Electronic Format – Submissions Under Section 745A(b) of the Federal F Medical Device and FDA Regulations and Standards News 0
M Informational TGA Consultation: Proposed clarification of the regulatory requirements for medical device systems and procedure packs Medical Device and FDA Regulations and Standards News 2
M Informational CDRH’s Regulatory Science Priorities Medical Device and FDA Regulations and Standards News 3
M Informational IMDRF draft document – Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews Medical Device and FDA Regulations and Standards News 0
D What foreign language proficiency would give the biggest edge to medical device regulatory affairs professionals in the world today or in future? Career and Occupation Discussions 6
M Informational Medicines and Healthcare Products Regulatory Agency Annual Report and Accounts 2018 to 2019 Medical Device and FDA Regulations and Standards News 0
M Informational IMDRF Consultation – Personalized Medical Devices – Regulatory Pathways Medical Device and FDA Regulations and Standards News 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
E EU Class 1s CE Mark Regulatory Pathway EU Medical Device Regulations 9
M Informational FDA Invites You to the 2019 Regulatory Education for Industry (REdI) Annual Conference Medical Device and FDA Regulations and Standards News 0
A Certification procedure for OEM/PLM collaboration in the medical device industry in the US - Who bears the regulatory responsability? Other US Medical Device Regulations 10
M Informational TGA – Q&A: Use of market authorisation evidence from comparable overseas regulatory bodies for medical devices Medical Device and FDA Regulations and Standards News 0
M Informational Health Canada has launched an e-Learning tool to aid in understanding the premarket regulatory requirements for medical devices in Canada Medical Device and FDA Regulations and Standards News 0
M Informational TGA Consultation: Proposed regulatory scheme for personalised medical devices, including 3D-printed devices Medical Device and FDA Regulations and Standards News 0
C Person Responsible for Regulatory Compliance - The RA guy/girl Employment Act EU Medical Device Regulations 4
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 Medical Device News TGA Consultation: Changes to a number of definitions and the scope of the medical device regulatory framework in Australia Medical Device and FDA Regulations and Standards News 0
M Medical Device News CDRH Research Programs – VICTRE: Virtual Imaging Clinical Trials for Regulatory Evaluation Medical Device and FDA Regulations and Standards News 0
M Medical Device News New Zealand – Therapeutic Products Regulatory Scheme consultation Medical Device and FDA Regulations and Standards News 0
supadrai My short yet eventful stint as a regulatory affairs lawyer dude is coming to an end! Career and Occupation Discussions 1
M Strategy for Foreign Regulatory Compliance Other Medical Device Regulations World-Wide 5
N Referencing of a standard's year in routine regulatory compliance documents Other Medical Device Related Standards 3
N Regulatory Responsibilities of an OEM and Private Label manufacturer Canada Medical Device Regulations 3

Similar threads

Top Bottom