Clue to UK's new regulatory requirements - approval of all devices placed on the market?

dgrainger

dgrainger

Trusted Information Resource
#1
#1
Yesterday saw the publication of the UK's Independent Medicines and Medical Devices Safety Review:

the Independent Medicines and Medical Devices safety Review - Oral hearings

In it is the following recommendation:

1.45 At present the MHRA has no involvement in the pre-market phase of medical​
device development. It should develop a proactive regulatory role for devices that is​
more akin to the licensing of medicines; this must be clinically focussed and at least​
as stringent as the new EU Medical Devices Regulations (MDR). The MHRA should​
keep a register of all devices approved for the UK market. Manufacturers should be​
required to apply to the MHRA before marketing their device. The MHRA should​
assess the application in a way that is proportionate to the risks posed taking into​
account relevant factors such as, the evidence base supplied, approvals in other​
jurisdictions, and the post-marketing surveillance plans. If approved a device will be​
added to the register. Marketing approval for devices should be a staged process,​
progressing to wider use and dissemination of the device as more information​
becomes available. In the event of an issue with a device the MHRA must have the​
power to remove a device from the register. Given there are an estimated 600,000​
or more devices on the market we recognise that initially this will almost certainly​
involve some ‘grandfathering’ of currently marketed devices.​
 
Standard Work Instruction Software by Dozuki
Elsmar Forum Sponsor
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
F Data Analysis Methods - No clue how to analyze this data Using Minitab Software 18
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
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
G Regulatory requirements for secondary packages in terms of label content Other Medical Device Regulations World-Wide 2
S Regulatory Certification Exam (RAC) - Global Scope ISO 13485:2016 - Medical Device Quality Management Systems 1
G ISO 13485:2016 and regulatory requirements - Contract Manufacturing ISO 13485:2016 - Medical Device Quality Management Systems 22
C ISO 13485 certified as precursor to regulatory compliance to 21 CRF Part 820? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7

Similar threads

Top Bottom