Quick question on responsible person's experience requirements

#1
Hi there, there is an opportunity for me to be trained as a Responsible Person as our company desperately needs one since the old one left and the most obvious candidate had a conflict of interest as explained by MHRA. We only deal with Chloraprep so risk is pretty low whether that makes a difference I don't know but this is my question:

I'm relatively young in terms of age and experience. I would have maybe 8 months of medicinal product distribution experience and I have a medical background in terms of education as well as a master's degree but that's it. My company is willing to sponsor the gold standard course for RP but I was wondering realistically what are my chances of being accepted by the MHRA? I don't meet the 1 year requirement/recommendation as I am not a pharmacist by trade.
 
Elsmar Forum Sponsor

twanmul

Involved In Discussions
#3
I'll assume that you're referring to Person Responsible for Regulatory Compliance as per MDR or IVDR rather than the UK Responsible Person and that the reference to the MHRA being involved in the suitability process means you're working out of Northern Ireland (and therefore MDR/IVDR apply there). If you're not based in Northern Ireland, then I can't see how the MHRA would have any say on the suitability of you being a PRRC under EU Regulations.
Being a PRRC for medical devices/IVD's isn't like an RP for GDP or like a QP for medical products. As such it isn't currently necessary to undertake a formal "course" or assessment for being a PRRC for medical devices/IVD's needed in order to fulfill the criteria set out in Article 15 of MDR & IVDR.
Having said this, if you have less than a year of experience in QA/RA for medical devices, then you don't meet the criteria (if you have a medical qualification then you do meet the criteria for the qualification as this is covered by qualifications in "law, medicine, pharmacy, engineering or another relevant scientific discipline"). There are two options left for you:
i. See if you qualify as a micro or small enterprise, in which case you wouldn't need a PRRC (Article 15, Subsection 2) , or;
ii. Contract out for 4 months, listing joint responsibility between you and the contract PRRC (as per Article 15, Subsection 4) until you have 12 months experience - at which point you can then remove the contractor and have you as the sole PRRC.
 

dgrainger

Trusted Information Resource
#4
For GB, "The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020"[1] substitutes UK RP for Authorised Rep into what was the MDD based regulations, so there aren't any qualification requirement!

If you're in NI, then the EUMDR & "The Medical Devices (Northern Ireland Protocol) Regulations 2021"[2] apply, and, as stated above, there is a experience requirement for the PRRC.

You can ask MHRA as they are still the Competent authority - [email protected]


1 - The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020
2 - The Medical Devices (Northern Ireland Protocol) Regulations 2021
 
Thread starter Similar threads Forum Replies Date
Q Quick question on the sequence of ISO 17025 external audits ISO 17025 related Discussions 14
M Quick Gage R&R Question Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 9
Ron Rompen Quick question on results of Student-t test Statistical Analysis Tools, Techniques and SPC 7
K When to create a new Control Chart? Quick question Statistical Analysis Tools, Techniques and SPC 4
J Salary / Rates for CMM Programmers in UK - Quick Question Career and Occupation Discussions 5
S I am asked to fit 2 lines - Basic Minitab Question - Quick Help needed Using Minitab Software 1
J LPAs (Layered Process Audits) and TS 16949 Clause 8.2.2.2 - Quick Question Process Audits and Layered Process Audits 20
A Quick question about RPNs - Any RPN over 100 should be actioned? FMEA and Control Plans 9
D Hey! Quick question, are any of these companies using 6 Sigma? Six Sigma 4
A Sterile Packaging Quick Query EU Medical Device Regulations 5
R Controlling Quick Reaction Checklists Document Control Systems, Procedures, Forms and Templates 1
O QRQC (quick response quality control) methodology in automotive industry IATF 16949 - Automotive Quality Systems Standard 3
C Quick - Tell me everything you know about TS 16949! LOL IATF 16949 - Automotive Quality Systems Standard 5
S What is an Efficient and Quick Salmonella Test Food Safety - ISO 22000, HACCP (21 CFR 120) 2
L Quick way to check spline pitch runout for machine operators Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
W TS16949 Quick Learning Material Training - Internal, External, Online and Distance Learning 1
F Suggestions for quick & effective solution for Continuous Improvement Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
M Plating - A quick, certifiable way to measure Plating Bath Temperature Manufacturing and Related Processes 3
P Cost Saving Excercises in Electronic Manufacturing - Quick and Efficient Lean in Manufacturing and Service Industries 2
H Quick Comparison Check of Multiple Thermocouples on one Datalogger General Measurement Device and Calibration Topics 6
Fender1 How to comply with ISO 9001 and provide quick/short lead-time orders? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
Q Quick Guide - Processes vs. ISO 9001 Clauses? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
J QRQC (Quick Response Quality Control) Training Material or Information Quality Tools, Improvement and Analysis 3
Q Quick ISO-TS 16949 Electronic Copy Cost Estimate IATF 16949 - Automotive Quality Systems Standard 2
1 Is anybody familar with Quick Response Manufacturing? Lean in Manufacturing and Service Industries 6
A Quick Transition ISO-9001 to TS-16949 IATF 16949 - Automotive Quality Systems Standard 6
bobdoering Quick Overview of SPC Scaling Factors from Wheeler Statistical Analysis Tools, Techniques and SPC 0
V Quick ISO 9001 Presentation for Internal Quality Auditors team needed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
L How to get an FDA approval before May 2010 - ?Quick and Dirty? FDA Approval 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 14
B Drunken Thread Inspection - Gauges for quick check for drunken threads General Measurement Device and Calibration Topics 3
B Quick and Simple Management System Review Spreadsheet? Quality Manager and Management Related Issues 7
A Changes to QRI (Quick Reference Instruction)? What I can or cannot change ISO 13485:2016 - Medical Device Quality Management Systems 2
G Video Example of Quick Setup Lean in Manufacturing and Service Industries 8
K Factory Quick Assessment Model - Assessment a small factory (<50 employee) Human Factors and Ergonomics in Engineering 8
G Quick Reference for the 8 Quality Management Principles in ISO 9000 IATF 16949 - Automotive Quality Systems Standard 2
N FORD Quick QFD (Quality Function Deployment) Document information wanted Customer and Company Specific Requirements 5
L Employee Morale Boosters - Low cost, quick, and easy ideas to boost morale Preventive Action and Continuous Improvement 31
D Quick and dirty training for team - Structured problem solving Six Sigma 21
Q Quick Overview of the Standards for Medical Devices - ISO 13485:2003 and ISO 14696? ISO 13485:2016 - Medical Device Quality Management Systems 5
E Digital Height Gauge Gage R&R - Need Advise and Help Quick Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
C Definition QRQC - Quick Response Quality Control - A problem solving tool Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 42
Wes Bucey Need a quick million? Got an unused website? After Work and Weekend Discussion Topics 5
P A Quick look at a failing business Career and Occupation Discussions 6
Al Rosen Quick Test - Are You 98% or 2%? You just thought about.... Coffee Break and Water Cooler Discussions 123
Al Rosen Quick Quiz Coffee Break and Water Cooler Discussions 23
B Request: Quick list of Required ISO9k2k RECORD Records and Data - Quality, Legal and Other Evidence 5
B The Idea Generator - Quick and Easy Kaizen Book, Video, Blog and Web Site Reviews and Recommendations 1
Marc Microsoft sez: Upgrade! Quick! After Work and Weekend Discussion Topics 1
M MTTR - Quick and dirty way to calculate Mean Time To Repair - Solenoid valves Statistical Analysis Tools, Techniques and SPC 6
Ed Panek Calibration question Manufacturing and Related Processes 4

Similar threads

Top Bottom