Guidance for health institutions on in-house manufacture and use

Michael Ayers

Starting to get Involved
#1
With the new EU Medical Device Regulations no longer becoming retained EU law within the UK (following Brexit), regulation of medical devices will largely revert back to the requirements set out in the old EU Medical Devices Directive (for now at least). One of the consequences of this is that medical devices manufactured and used within a single health institution will continue to fall outside the scope of the UK regulations.

With this in mind, IPEM have developed best practice guidance on manufacturing medical devices within health institutions. It can be found through the following link:

IPEM > Scientific Journals & Publications > Free Publications
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
M Informational Health Canada guidance document – Pre-market Requirements for Medical Device Cybersecurity Medical Device and FDA Regulations and Standards News 0
M Informational Health Canada – Notice: Revisions to the Guidance Document: Management of Applications for Medical Device Licences Medical Device and FDA Regulations and Standards News 0
L Medical Device Accessory - Health Canada guidance / definition on what an accessory is Canada Medical Device Regulations 3
M Informational Health Canada – Guidance Document: Supporting Evidence for Implantable Medical Devices Manufactured by 3D Printing Medical Device and FDA Regulations and Standards News 0
M Informational Publication of Draft Health Canada Implementation Guidance for the International Medical Device Regulators Forum Table of Contents Format Medical Device and FDA Regulations and Standards News 0
O Guidance Regarding Career In Health Information Management Career and Occupation Discussions 0
M Informational UK – Brexit operational readiness guidance for the health and care system in England Medical Device and FDA Regulations and Standards News 3
bio_subbu USFDA issues final guidance on "Reprocessing Medical Devices in Health Care Settings" Other US Medical Device Regulations 1
M Health Canada Private Label Guidance Confusion - Quality System Required? Canada Medical Device Regulations 5
T Health Canada Class III/IV "Significant Change" guidance interpretation Canada Medical Device Regulations 2
E Guidance on the regulation (CE Marking) of Health Apps IEC 62304 - Medical Device Software Life Cycle Processes 2
bio_subbu Health Canada's guidance on Class IV Device Electronic Premarket Review Submission Canada Medical Device Regulations 0
I ANDA Human Factors Guidance US Food and Drug Administration (FDA) 0
Watchcat New Draft Guidance on Content of Premarket Submissions for Software Device "Functions" Other US Medical Device Regulations 2
Watchcat CDRH Proposed New Guidance Documents, FY2022 Other US Medical Device Regulations 2
K Guidance on X-Ray Medical Devices for Animal Use - FDA US Food and Drug Administration (FDA) 0
dgrainger Informational MDCG 2021-24 - Guidance on classification of medical devices EU Medical Device Regulations 0
J Can we register non-device clinical decision support software under draft guidance? Other US Medical Device Regulations 5
S In Need of GIDEP Guidance AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
A Can anyone explain UKRP guidance relating to Northern Ireland? UK Medical Device Regulations 2
Ajit Basrur Any ISO standard or guidance documents on barcode and scanning? Other Medical Device Related Standards 1
B What is the difference btw RUO vs IUO for IVD in FDA guidance ? US Food and Drug Administration (FDA) 12
D FDA Guidance on Computer Software Assurance versus 21 CFR Part 11 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
G Does FDA allows remote approvals of quality documentation. Is there any specific guidance on signing any quality records remotely? Document Control Systems, Procedures, Forms and Templates 1
N Guidance - Cost of Good Quality Misc. Quality Assurance and Business Systems Related Topics 2
Sidney Vianna Interesting Discussion Should ISO 9004 be changed from a guidance document to a requirements standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
Sidney Vianna Release of ISO 10013:2021, Quality management systems – Guidance for documented information Other ISO and International Standards and European Regulations 0
M Labelling - Is there a guidance or regulations that specifically defines the 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Need guidance on project ISO 13485:2016 - Medical Device Quality Management Systems 2
dgrainger Informational MHRA guidance on CE UKNI - Article 5.5 - 2021-02 EU Medical Device Regulations 0
R Quality System Functional Safety Checklist / Guidance IATF 16949 - Automotive Quality Systems Standard 0
K Looking for guidance to write an SOP on Statistical Methodologies? Statistical Analysis Tools, Techniques and SPC 7
A 21 CFR 820 - Risk Management - Looking for some guidance US Food and Drug Administration (FDA) 3
A Which guidance do you use for guiding the requirements of IFU for 510(k) submission? Medical Device and FDA Regulations and Standards News 5
M Minimum sample size - Guidance and statistical rationale Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
A FDA guidance on non-sterile Medical Device Packaging Medical Device and FDA Regulations and Standards News 7
Aymaneh AAMI TIR45 guidance wanted IEC 62304 - Medical Device Software Life Cycle Processes 4
M FDA News FDA Releases Draft Guidance Clarifying Application of ISO 10993-1 Biocompatibility Standard Medical Device and FDA Regulations and Standards News 0
D GMDN code update - Canada - Do you know if there is guidance? Canada Medical Device Regulations 0
D Where to find Guidance Class II Amendment Canada Medical Device Regulations 1
dgrainger Informational UK guidance on Device regulation from Jan 2021 published UK Medical Device Regulations 19
shimonv FDA News FDA guidance on Multiple Function Device Products (8/2020) Other US Medical Device Regulations 1
K FDA Premarket Cybersecurity Guidance - 4 questions Other US Medical Device Regulations 5
B EU MDR Perscription product guidance EU Medical Device Regulations 1
John Broomfield Guidance on Safe Working During Covid-19 Pandemic Misc. Quality Assurance and Business Systems Related Topics 5
dgrainger Informational UK guidance on FSNs - May 2020 EU Medical Device Regulations 1
dgrainger Informational UK guidance on FSNs - Published 20 May 2020 UK Medical Device Regulations 1
W Seeking Guidance Verification Test Strategy for Class B Medical Devices IEC 62304 - Medical Device Software Life Cycle Processes 1
S What is considered a "core algorithm"? (From an FDA guidance document) Medical Information Technology, Medical Software and Health Informatics 4
Stoic Are any medical device companies using the 2011 FDA process validation guidance instead of GHTF/SG3/N99-10:2004? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1

Similar threads

Top Bottom