Medical Device News EU – Transition Timelines from the Directives to the Regulations – Medical Devices and in vitro Diagnostic Medical Devices

#11
To meet the new EU Medical Device Regulation objective, organisations will need to take a structured and well-managed approach over the next coming years depending on the product portfolio.
 
Elsmar Forum Sponsor
#12
No, self-declared medical devices have to comply with the MDR in the date of application (May 2020). Only class I M or S device (which have a valid certificate) may continue to be put into the market under the MDD.
I understand that Article 120 paragraph 4 states that self-declared medical devices (class I) can't be placed on the market after 26 may 2020. Could you elaborate on wether these self-declared class I medical devices can still be made available on the market/put into service?
 

Shawna

Starting to get Involved
#13
After May 2020, self declared device need to comply with the regulation requirements of MDR in order to be placed on the market, except the class I device in S or M category

I understand that Article 120 paragraph 4 states that self-declared medical devices (class I) can't be placed on the market after 26 may 2020. Could you elaborate on wether these self-declared class I medical devices can still be made available on the market/put into service?
 
Thread starter Similar threads Forum Replies Date
J MDD to MDR transition - Time required for the implementation of the MDR EU Medical Device Regulations 7
S MDR consultants - in search of recommendations for a consultant for MDR transition. Paid Consulting, Training and Services 7
K Annex XVI Device Transition Timeline under the MDR EU Medical Device Regulations 2
B ISO 9001:2015 Transition: Much Easier Than You Think! Misc. Quality Assurance and Business Systems Related Topics 0
M UDI transition period and implementation EU Medical Device Regulations 6
M Informational The US FDA is Recommending Transition to Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication Medical Device and FDA Regulations and Standards News 0
O New MDR 2017/745 Transition Strategy - 2019 Manufacturing and Related Processes 3
A How to manage the QMS system and SOP during the transition from MDD to MDR EU Medical Device Regulations 4
S When is the last date for transition to ISO/IEC 80079-34:2018? Other ISO and International Standards and European Regulations 0
K CE mark transition and new regulations CE Marking (Conformité Européene) / CB Scheme 0
Ronen E Informational ISO 13485:2016 Transition Period End - 1 March 2019 ISO 13485:2016 - Medical Device Quality Management Systems 0
T MDR Guidance Book - Useful for MDR transition? EU Medical Device Regulations 1
H Transition to ISO 13485:2016 together with ISO 9001:2015 ISO 13485:2016 - Medical Device Quality Management Systems 12
Ed Panek Transition to IEC 60601 4th Edition - Risk Analysis and test submissions CE Marking (Conformité Européene) / CB Scheme 2
M Medical Device News Health Canada - Medical Device Single Audit Program (MDSAP) Transition Plan Canada Medical Device Regulations 2
M Medical Device News FDA News - 26-09-18 - FDA Reveals Vision for the Transition to ISO 13485 Other US Medical Device Regulations 1
M MDSAP Transition - Health Canada Website Notice on Apr 13 2018 Canada Medical Device Regulations 1
O IEC 60601-1-2 4th edition transition deadline Dec 31 2018 CE Marking (Conformité Européene) / CB Scheme 1
Q Transition and recertification at the same time? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
P How To Transition From AS9100c to AS9100 Rev. D AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 6
A ISO 14001:2015 transition from the 2004 standard ISO 14001:2015 Specific Discussions 8
F IATF 16949:2016 transition audit - Internal Audit Closures IATF 16949 - Automotive Quality Systems Standard 13
W AS9120A to AS9120B transition AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
L Transition date to IEC 60601-1-11:2015 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
Q Surveillance Audit of 2008 before Transition Audit to ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
B Going into IATF 16949 transition without Internal Audits IATF 16949 - Automotive Quality Systems Standard 4
pammesue We have done NOTHING toward the ISO 9001 transition ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
S Management representative transition checklist IEC 27001 - Information Security Management Systems (ISMS) 7
O ISO 9001:2015 Transition Internal Audit completion thread ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
A ISO 14001:2015 transition audit - Major NC due to the procedure and audit plan ISO 14001:2015 Specific Discussions 10
T ISO 9001:2008 to 2015 transition - How much work to change? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
R ISO 9001:2015 Transition Quality Manual Update - Redundant Content ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
G Upkeep of ISO 9001:2008 during Transition TO ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
D AS9110 Re-Certification & Transition Audit AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 0
S Is there enough time left to transition to ISO 13485:2016 and MDSAP? ISO 13485:2016 - Medical Device Quality Management Systems 1
M AS9100 Rev. D Transition Audit - Number of Audit Days AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
G Effect of ISO9001 2015 transition on ISO IEC 80079-34 Other ISO and International Standards and European Regulations 2
R Who here is Using a Consultant for ISO 9001 Transition? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Sidney Vianna One year to ISO 9001 and 14001 transition deadline. ISO & IAF communique' ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
Sidney Vianna IATF bringing stakeholders together to ensure Transition by the 2018-09-14 deadline IATF 16949 - Automotive Quality Systems Standard 10
D Number of Audit Days - AS9100D Transition for a Small Shop AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 3
Ronen E Transition to MDR (EU 2017/745) - I'd like to make an offer EU Medical Device Regulations 12
Q Presentation for Employees - Starting the ISO 9001:2015 Transition ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
K AS9100 Rev. D Transition - Internal Audits & Gap Analysis Requirements AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 14
M Who has had a Transition Audit from TS 16949 to IATF 16949 IATF 16949 - Automotive Quality Systems Standard 120
S Question for those who have completed Transition Audit for ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
O Guidance and/or assistance on Transition to AS9100 Rev D AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 11
M Multi-Site Umbrella Certification Transition Plan ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
D Internal Audit During the Transition Period from ISO9001:2008 to ISO9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
T Has anyone completed the AS9100D Quality Manual transition? Quality Management System (QMS) Manuals 1
Similar threads


















































Top Bottom