Informational MHRA updated guidance: Clinical investigations of medical devices – guidance for manufacturers

Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
M Informational MHRA guidance updated to reflect the mDR – Clinical investigations of medical devices – Biological safety assessment Medical Device and FDA Regulations and Standards News 1
M Informational MHRA – Virtual manufacturing of medical devices – Updated guidance Medical Device and FDA Regulations and Standards News 1
K UKRP Registration with MHRA UK Medical Device Regulations 0
dgrainger Informational MHRA's Software and AI as a Medical Device Change Programme UK Medical Device Regulations 0
K Technical file for MHRA - looking for assistance with self declaration Class I device CE Marking (Conformité Européene) / CB Scheme 8
dgrainger New decision by MHRA on disclaimers - addition of "manner of use as perceived by the consumer" UK Medical Device Regulations 1
D Low risk IVD study in the UK, do I need MHRA approval? UK Medical Device Regulations 1
dgrainger Informational MHRA - Regulating medical devices in the UK - Post Brexit - 2021-02 UK Medical Device Regulations 0
dgrainger Informational MHRA guidance on CE UKNI - Article 5.5 - 2021-02 EU Medical Device Regulations 0
S How long does it take to register a product with MHRA? UK Medical Device Regulations 14
dgrainger Informational MHRA guidance update on withdrawal of Notified Bodies Medical Device and FDA Regulations and Standards News 0
dgrainger MHRA - Creation of new UK Responsible Person section with added content. Medical Device and FDA Regulations and Standards News 0
M Informational MHRA guidance – Assistive technology: definition and safe use Medical Device and FDA Regulations and Standards News 0
M Informational MHRA Guidance – Dental radiographic X-ray imaging: dose to patients Medical Device and FDA Regulations and Standards News 0
M Informational MHRA launches consultation on how to best engage patients and the public Medical Device and FDA Regulations and Standards News 0
M Informational MHRA update – Medical devices: guidance for manufacturers on vigilance - June 2019 Medical Device and FDA Regulations and Standards News 0
M Informational MHRA Guidance – Recommendations from the independent Expert Advisory Group on the use of Paclitaxel Drug-Coated Balloons (DCBs) and Drug-Eluting Stent Medical Device and FDA Regulations and Standards News 0
dgrainger MHRA guidance on Virtual manufacturing - version 2 EU Medical Device Regulations 1
M Medical Device News MHRA releases response to consultation on EU exit no-deal legislative proposals Medical Device and FDA Regulations and Standards News 0
M Medical Device News MHRA – Field safety notices – 03 to 07 December 2018 Medical Device and FDA Regulations and Standards News 1
DMLqms Informing MHRA re. EC Certs expiry. EU Medical Device Regulations 3
M Medical Device News MHRA to consult on EU exit no-deal legislative proposals EU Medical Device Regulations 1
Q MHRA has released a new guidance document related to 'GXP' Data Integrity EU Medical Device Regulations 3
C First Aid Kit Compliance advice - Registered assembler with the MHRA EU Medical Device Regulations 1
F IVD/Medical Device Registration (with MHRA DORS account in the UK) EU Medical Device Regulations 3
I MHRA - Virtual Manufacturer Document Requirements EU Medical Device Regulations 2
B MHRA Unannounced Audits Frequency Changed? EU Medical Device Regulations 2
JoCam Incident Reporting MHRA (Medical & healthcare regulatory agency) EU Medical Device Regulations 3
M New MHRA guidance on Human Factors - Usability Engineering IEC 62366 - Medical Device Usability Engineering 1
V Data Quality and Data Integrity - Audit Trail - Part 11 - WHO - FDA - MHRA - PDA US Food and Drug Administration (FDA) 6
bio_subbu MHRA issues guidance on Medical Device stand-alone software (including apps) EU Medical Device Regulations 1
L Status of Certificate of Free Sale Transfer to MHRA - 1 April 2014 Other Medical Device and Orthopedic Related Topics 3
C When will my company get an MHRA Audit and Inspection? EU Medical Device Regulations 3
Ronen E MHRA Publishes Guidance for Notified Bodies on Regulation of IVDs for Self Testing EU Medical Device Regulations 0
M MHRA (Medical & Healthcare Regulatory Agency) Design Dossier Review Delays EU Medical Device Regulations 2
P Anyone heard about UK MHRA's MDDL? What is it going to lead to? Professional Certifications and Degrees 3
I MHRA and Class 1 Medical Device - Using the RG2 form ISO 13485:2016 - Medical Device Quality Management Systems 5
bio_subbu MHRA - Draft guidance on specific device vigilance reporting EU Medical Device Regulations 0
chris1price Loss of CE Mark - MHRA decided that they are not Medical Devices EU Medical Device Regulations 10
Watchcat REGULATORY WATCHCAT - De novo info updated and consolidated Other US Medical Device Regulations 0
B Updated IATF 16949 - Will IATF 16949 get revised when ISO 9001:202X is released? IATF 16949 - Automotive Quality Systems Standard 4
K Updated MSA with the Annual PPAP validations APQP and PPAP 8
R Do we need issue ECN (Engineering Change Notice) towards updated Material Specification? Design and Development of Products and Processes 2
Ed Panek Compliance with Standards? When a standard is updated/revised CE Marking (Conformité Européene) / CB Scheme 3
R Shall a new UDI-DI be required when stand-alone software device's version is updated? EU Medical Device Regulations 1
P Cenelec updated standard information CE Marking (Conformité Européene) / CB Scheme 1
W Updated EU MDR regulatory matrix wanted ISO 13485:2016 - Medical Device Quality Management Systems 46
M Informational Updated US FDA Resources for Third Party Review Organizations Medical Device and FDA Regulations and Standards News 0
dgrainger Informational Updated Borderlines manual - Version 1.22 (05-2019) EU Medical Device Regulations 0
M Which documents must be updated upon product validation? Document Control Systems, Procedures, Forms and Templates 1

Similar threads

Top Bottom