What is the European UDI implementation timeline?

F

Frypot

Starting to get Involved
Hi,
I'm having a tough time trying to find an indication of when the UDI for medical devices will become a legal requirement.
I am aware they are likely to be rolled out in risk priority; i.e. Class III first and ending with Class I, but what the proposed scheduling is I can't seem to find.
Anyone got an idea?
 
ScottK

ScottK

Not out of the crisis
Leader
Super Moderator
This is what GS1 has to say:

UDI update - are you ready for 2017?

In the US the compliance date for Class 3 medical devices was September 2014. This means that if you are supplying product into the US, a condition of sale is that there is a UDI (standardised barcode with ID and batch information) on the product packaging. The compliance dates are staggered over the next few years to support implementation by suppliers.

A similar regulation is expected to take effect in 2017 for EU member states.
Click to expand...

http://www.gs1ie.org/Healthcare/Sectors/Medical-Devices/
 
Ronen E

Ronen E

Problem Solver
Moderator
Hi,

I think that the whole timeline for EC Medical Devices regulation changes is a bit foggy. A massive change (MDD -> MD Regulation) is in the making a long time, and is affected by political clashes of all sorts. 2017 may be one of the estimates for completion, but I wouldn't regard it as too meaningful.

Cheers,
Ronen.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
A European UDI-DI CE Marking (Conformité Européene) / CB Scheme 2
N Will an FDA UDI be compatible with a European MDR UDI? EU Medical Device Regulations 7
H European requirements for rechargeable Lithium-ion batteries going to be used in Electronic Pipette CE Marking (Conformité Européene) / CB Scheme 0
H Audit Checklist for European Authorized Representative EU Medical Device Regulations 0
H Regarding confusion of the validity of the European implementation of IEC standards Other Medical Device Related Standards 1
C European Technical File for registration in Australia CE Marking (Conformité Européene) / CB Scheme 5
P European Medical Device Nomenclature (EMDN) and CND EU Medical Device Regulations 13
B European Harmonized vs IEC standard IEC 62366 - Medical Device Usability Engineering 2
P Requirements for being an European Representative EU Medical Device Regulations 3
P Best european location to set up for a virtual medical device manufacturer? EU Medical Device Regulations 4
F How to register class I device to all European Competent Autorities(CA) when we are European manufacturer EU Medical Device Regulations 4
dgrainger Medical Device News MDR postponed - link to Official Journal of the European Union (24-4-2020) EU Medical Device Regulations 2
P European versions of standards - ISO 10993-1 and ISO 11607-1 EU Medical Device Regulations 6
shimonv Recall - Is there a European regulation for recalls of products EU Medical Device Regulations 5
atitheya Need of conducting medical trials in European Union EU Medical Device Regulations 2
P ISO 10993-1:2018 - When will the European equivalent become a Harmonized Standard? Other Medical Device Related Standards 13
M Informational TGA – European implementation of Medical Device and IVD Regulations – Implications for Australia Medical Device and FDA Regulations and Standards News 0
M Informational EU – Guidance document Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 of the European Parliament and of the Council o Medical Device and FDA Regulations and Standards News 2
M Informational European Commission expert panels on medical devices and in vitro diagnostic devices Medical Device and FDA Regulations and Standards News 0
Marc European universities dismal at reporting results of clinical trials - 2019 Other Medical Device Regulations World-Wide 0
M Informational Medtech Europe – Open letter to the European Commission on the implementation and readiness status of the new Medical Device Regulation (MDR) Medical Device and FDA Regulations and Standards News 0
M Informational Technology and innovation of human implants | Panel for the Future of Science and Technology (STOA) | European Parliament Medical Device and FDA Regulations and Standards News 0
M Informational EU – Draft Functional specifications for the European Database on Medical Devices (Eudamed) – First release (High(1)) to be audited Medical Device and FDA Regulations and Standards News 0
moounir Medical Device Nomenclature - Free of Charge? (European Union MDR MDR 2017/745) EU Medical Device Regulations 7
M Informational EU – Questions And Answers Related To The United Kingdom’s Withdrawal From The European Union With Regard To Industrial Products Medical Device and FDA Regulations and Standards News 0
N European Authorised Representative (also called Authorized Representative) - Cost competitive recommendation EU Medical Device Regulations 1
Marc Regulation (EU) 2017/745 of the European Parliament EU Medical Device Regulations 13
J Medical Device Registration in Argentina - Client asks us to provide “European FSC” Other Medical Device Regulations World-Wide 4
S CE ETA (A2) Audit - CE mark for the european construction market CE Marking (Conformité Européene) / CB Scheme 0
M Medical Device News MedTech Europe - European Parliament further clarifies Commission proposal on HTA for medical technologies EU Medical Device Regulations 0
W Sale medical device to European Hospitals Hospitals, Clinics & other Health Care Providers 1
R Brexit - European Commission - The impact of the Brexit per March 29, 2019 EU Medical Device Regulations 3
E European Weld Callouts - Confused with the "/C" and the "a2" portions Various Other Specifications, Standards, and related Requirements 7
H European Pharmacopoeia First Identification Requirements Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
Q IVD vs EMC OJ (Official Journal of the European Union) Harmonised Standard Conflicts EU Medical Device Regulations 1
S Medical Device Registration & Technical Format/Template - European Union CE Marking (Conformité Européene) / CB Scheme 8
L ISO 13485 and European GMP ISO 13485:2016 - Medical Device Quality Management Systems 3
E European Regulations defining the terms Repair and Refurbish EU Medical Device Regulations 5
Marc Definition PEPPOL - Pan-European Public Procurement Online Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 0
J Label translation requirements for EU (European Union) EU Medical Device Regulations 3
U What if UK leaves EU? What will happen to European Authorized representative in UK? EU Medical Device Regulations 22
rob73 New MDD (European Medical Device Regulations) next steps - 2016 EU Medical Device Regulations 1
E I'm looking for old publications of European Quality in pdf Book, Video, Blog and Web Site Reviews and Recommendations 2
K May 16 2014 Official Journal of the European Union Publication - 60601-2-33 EU Medical Device Regulations 3
M Overview of European Regulations of Medical Device Other ISO and International Standards and European Regulations 12
Ajit Basrur Is there an European equivalent of FDA Debarment List? EU Medical Device Regulations 2
P Is the European directive, 2011/65/EU applicable for Engineering Samples? RoHS, REACH, ELV, IMDS and Restricted Substances 5
Stijloor The European Union Explained Coffee Break and Water Cooler Discussions 4
E Current MRI Labeling requirement for European Union CE Marking (Conformité Européene) / CB Scheme 2
J0anne US Working Permit Requirements for European Consultants Career and Occupation Discussions 2

Similar threads

Top Bottom