Regulatory Approval for similar Medical Devices

JoCam

Trusted Information Resource
#1
Hi All,

If I wish to submit two identical medical devices for regulatory approval (class II in Europe) differing only in size, would I have to submit 2 separate applications or can they be treated as one and it's variant? The devices in question are catheters for insertion during laparoscopic procedures.

Thank you in advance,

Jo
 
Elsmar Forum Sponsor

SteveK

Trusted Information Resource
#2
Re: Regulatory Approval for similar devices

I would have thought that it would be no problem if you can cover both in one Technical File i.e. a ?family? of like products. I have had no problems with our NB with variants in my TFs which cover items of different design but which do essentially the same job.

Steve
 
Thread starter Similar threads Forum Replies Date
dgrainger Clue to UK's new regulatory requirements - approval of all devices placed on the market? Other Medical Device Regulations World-Wide 1
JoCam Cost of maintaining CE Mark Regulatory Approval Other Medical Device Regulations World-Wide 3
S Regulatory Approval(s) for Rework Dispositions Nonconformance and Corrective Action 2
D Regulatory Approval for "Research Use Only" Medical Devices Other US Medical Device Regulations 9
F Medical Device Regulatory Approval Example to share with my students EU Medical Device Regulations 2
A Central/South America Regulatory Approval Other Medical Device Regulations World-Wide 8
V Medical Device Regulatory Approval Process Charts ISO 13485:2016 - Medical Device Quality Management Systems 0
B Changing a Class II product's name after/during regulatory approval Other Medical Device and Orthopedic Related Topics 2
R Control of Nonconforming Product - Customer and/or Regulatory Approval ISO 13485:2016 - Medical Device Quality Management Systems 4
S Procedure Approval - SOPs signed by the President and Regulatory Affairs ISO 13485:2016 - Medical Device Quality Management Systems 5
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
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

Similar threads

Top Bottom