Final Medical Device Regulations replacing MDD 93/42/EEC, etc.

Elsmar Forum Sponsor

L_O_B

Involved In Discussions
#5
Re: Final Medical Device Regulations?

Put the documents side to side and take a look at the pages. There is not a lot more text. They just decided to only use 2/3 of the space of each page. Also the number of articles stays the same: 123. The numbering changed though. Keep calm, there are some important changes but most of the differences are simply another wording compared to the version of August 2016.
 

Marcelo

Inactive Registered Visitor
#7
Re: Final Medical Device Regulations replacing MDD 93/42/EEC, etc?

The differing number of pages is due to the formatting required to be published in the official journal, but the text is very likely the one from the last draft.
 

Chrisx

Involved In Discussions
#8
Re: Final Medical Device Regulations replacing MDD 93/42/EEC, etc?

I'm debating about creating bookmarks for the various articles. I did this for the draft and it makes it much easier to navigate. It's a significant job to bookmark the whole thing. Is this document now completely final or is it open to some final edits?
 

dgrainger

Trusted Information Resource
#9
Re: Final Medical Device Regulations replacing MDD 93/42/EEC, etc?

It still needs to go to the EP - hopefully without change!

PS there is a lot of white space in this version.
 

lewisking34

Starting to get Involved
#10
Re: Final Medical Device Regulations replacing MDD 93/42/EEC, etc?

Hi,

Assuming the MDR is officially published after passing through European Parliament, it becomes law across the EU with a 3 year transition/phase-in period (in layman's terms).

Although in the midst of leaving the EU, the MDR will come into effect in the UK after being published. We, in the UK, will all have to work towards the new MDR in the transition phase... however after the UK leaves the EU, presumably in mid-2019, will we still have to work towards the MDR?

I understand the law is the law, and initially I thought the answer was 'obviously yes', however on reflection, I'm not so sure... this one has clouded my thinking a little so I'd like to hear anyone else's thoughts.

All the Best,
Lewis
 
Thread starter Similar threads Forum Replies Date
M Informational US FDA Final Guidance – Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classificati Medical Device and FDA Regulations and Standards News 0
V Removing final inspector for medical device manufacturing Lean in Manufacturing and Service Industries 4
M FDA News USFDA Final Rule – Medical Device Classification Procedures: Incorporating Food and Drug Administration Safety and Innovation Act Procedures Medical Device and FDA Regulations and Standards News 0
M FDA News The FDA Issues Final Rule on Medical Device Classification Procedures Medical Device and FDA Regulations and Standards News 0
JoCam Medical Device Final Assembly Labelling EU Medical Device Regulations 2
M Design Inputs - Final Medical Device Specifications 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
R Medical Device Software - Final Field Testing Best Practices IEC 62304 - Medical Device Software Life Cycle Processes 5
K When to do Final Release if Medical Device goes off site prior to shipping? ISO 13485:2016 - Medical Device Quality Management Systems 5
M Informational Final guidance – GUIDELINES on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carc Medical Device and FDA Regulations and Standards News 0
M Informational USFDA Final Guidance – Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices) Medical Device and FDA Regulations and Standards News 0
M Informational USFDA Final Rule – Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices Medical Device and FDA Regulations and Standards News 0
M FDA News USFDA Final Guidance – Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements Medical Device and FDA Regulations and Standards News 0
S 100% Final Inspection Requirements of Active Medical Devices (MDD or IEC Standards?) EU Medical Device Regulations 4
bio_subbu USFDA issues final guidance on "Reprocessing Medical Devices in Health Care Settings" Other US Medical Device Regulations 1
Ajit Basrur FDA issues Final Guidance on Mobile Medical Apps (Applications) US Food and Drug Administration (FDA) 2
sagai Mobile Medical Applications Final Guidance Released Other US Medical Device Regulations 0
bio_subbu CDSCO Issues final guidance documents on Registration & Import of Medical Devices Other Medical Device Regulations World-Wide 0
I Mother bobbin final inspection criteria Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
D Using non-conforming components even though the final assembly is conforming? Manufacturing and Related Processes 5
M Informational EU – MDCG 2019-12 Designating authority’s final assessment form: Key Information Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Final Guidance – Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Final Guidance – Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings – Labeling Considerations Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Final and update guidances – Software Medical Device and FDA Regulations and Standards News 2
M Informational USFDA final guidance – Safety and Performance Based Pathway Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Final Guidance – Special Premarket Notification [510(k)] Pathway Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Final Guidance – Acceptance Review for De Novo Classification Requests Medical Device and FDA Regulations and Standards News 1
M Informational US FDA Final Guidance – Humanitarian Device Exemption (HDE) Program Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Final guidance – Postmarketing Safety Reporting for Combination Products Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Final guidance – Metal Expandable Biliary Stents – Premarket Notification (510(k)) Submissions Medical Device and FDA Regulations and Standards News 0
M Informational US FDA – Requests for Supervisory Review of Certain Decisions Made by the Center for Devices and Radiological Health – Final Rule Medical Device and FDA Regulations and Standards News 0
M Informational US FDA final guidance – Marketing Clearance of Diagnostic Ultrasound Systems and Transducers Medical Device and FDA Regulations and Standards News 0
M Informational US FDA final guidance – Utilizing Animal Studies to Evaluate Organ Preservation Devices Medical Device and FDA Regulations and Standards News 0
M Informational US FDA final guidance Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices Medical Device and FDA Regulations and Standards News 0
M Informational USFDA final guidance – Unique Device Identification: Convenience Kits Medical Device and FDA Regulations and Standards News 0
M Informational USFDA final guidance – Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions Medical Device and FDA Regulations and Standards News 0
T Final process capability results - What I am supposed to present? Cp and CpK? APQP and PPAP 11
M Informational IMDRF final document – Assembly and Technical Guide for IMDRF Table of Contents Submissions Medical Device and FDA Regulations and Standards News 4
A Doubt on multiple inspection carrying out for same balloon number during Stage Inspection and Final Inspection? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
M Informational USFDA Final Guidance – Safety and Performance Based Pathway Medical Device and FDA Regulations and Standards News 2
M Informational USFDA Final Guidance – Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices Medical Device and FDA Regulations and Standards News 0
M Informational USFDA Final Guidance – The Least Burdensome Provisions: Concept and Principles Medical Device and FDA Regulations and Standards News 0
M FDA News USFDA Final Report – MDUFA IV Independent Assessment of FDA’s Device Review Process Management Medical Device and FDA Regulations and Standards News 0
M FDA News USFDA – Breakthrough Devices Program final guidance Medical Device and FDA Regulations and Standards News 0
M FDA News USFDA Final Guidance – Manufacturing Site Change Supplements: Content and Submission Medical Device and FDA Regulations and Standards News 1
M Medical Device News FDA News - 03-10-18 - CDRH FY 2019 Proposed Guidance Development and Focused Retrospective Review of Final Guidance Other US Medical Device Regulations 0
M CE / FCC Compliance for components + final product CE Marking (Conformité Européene) / CB Scheme 2
shimonv FDA released final guidance documents on what constitutes a significant change Other US Medical Device Regulations 2
T Primary & Secondary Inspection Definitions - Incoming, In-process & Final Inspection Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
C Serialization at Final Quality Check ISO 13485:2016 - Medical Device Quality Management Systems 3
M 2016 FDA Final Guidance for Blood Glucose Monitoring Systems - Implementation Other US Medical Device Regulations 2

Similar threads

Top Bottom