SBS - The Best Value in QMS software

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
S

SteveK

#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
P Quality and Regulatory organizational structure Consultants and Consulting 2
M Supplier approved list - Notified body, regulatory body Supply Chain Security Management Systems 4
B Regulatory Affairs Certification (RAC) Book - Fundamentals of Medical Device Regulations Medical Device and FDA Regulations and Standards News 0
Watchcat REGULATORY WATCHCAT - De novo info updated and consolidated Other US Medical Device Regulations 0
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 Reliable sources for following EU medical device regulatory EU Medical Device Regulations 0
A GPS Regulatory requirements? Manufacturing and Related Processes 6
C RA (Regulatory Assurance) Training (FDA) looking for resources Training - Internal, External, Online and Distance Learning 5
H SOP Template for seeking regulatory clearance - MDSAP Document Control Systems, Procedures, Forms and Templates 6
J Strategy for MDR Regulatory Compliance Procedure ISO 13485:2016 - Medical Device Quality Management Systems 4
K Regulatory requirement of SaMD with machine learning component IEC 62304 - Medical Device Software Life Cycle Processes 3
P Regulatory or registration requirement for disinfectant in ASEAN Registrars and Notified Bodies 1
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 3
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 1
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 42
J Management Representative and PRRC (Person Responsible for Regulatory Compliance) ISO 13485:2016 - Medical Device Quality Management Systems 11
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 3
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 46
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

Similar threads

Top Bottom