Transition Period for MEDDEV 2.7.1

Yasuaki

Starting to get Involved
#1
Website of TEAM-NB (Article in Scrip Regulatory Affair by Vibha Sharma) shows MEDDEV 2.7/1 is going to be revised in May.

This revision seems to be very serious from the description.

If this revision suddenly apply all medical devices, no medical devices can be placed on EU market for some time.

So, I think transition period must be given.

However, there is no description related to transition period.
Does anyone give us information about transition period?

Thank you.
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#3
MedDevs are guidance, not mandatory, so there can't be a transition period attached to them.
Technically this is true but in the case of MEDDEV 2.7.1 it's practically what the NB audit by (at least the serious ones). I assume that there will be some sort of transition de-facto, though it probably won't be stated in a formal way.
 

Yasuaki

Starting to get Involved
#4
Technically this is true but in the case of MEDDEV 2.7.1 it's practically what the NB audit by (at least the serious ones). I assume that there will be some sort of transition de-facto, though it probably won't be stated in a formal way.
Thank you for your comment.

Anyway, it seems to be necessary to ask Notified Body of our company carefully.
 

RobertvanBoxtel

Involved In Discussions
#5
Formally, MEDDEV's are guidances. However, they also demonstrate the latest position of the European Commission.
The information included in the MEDDEV 2.7.1 rev 4 (based on the draft text) will require time by manufacturers to be implemented. Your Notified Body will verifiy how you comply and determine in case of gaps what the most appropriate actions will be for you to ensure you will comply. This gives manufacturers time to comply.
Please realize: when regulations or guidances change, existing medical devices with good track records don't suddenly become unsafe.
Everybody is very much interested to see how NB's will handle this.
But one recommendation: Enforce PMCF throughout your organization and start gathering actual clinical use feedback on your device by CRF's, meeting with experts etc. Also for low risk devices! If you can't show data on your device, eventually the door will be closed.
 

Marcelo

Inactive Registered Visitor
#6
I don't disagree that the MEDDEV is used by NBs (although they should probably be using the NBOG document, not the MEDDEV :p). But the OP mentioned that he thought a transition period should be given. It won't.

Another comment from the OP is also not true:
If this revision suddenly apply all medical devices, no medical devices can be placed on EU market for some time.
As a guidance, the document has no legal force for placing on the market.

On the other hand, as it is used, manufacturers should have a plan, as quickly as possible, on how to address the changes, as Robert mentioned. And then discuss with the NB. I think there may be cases where the EC certificate may be held until a updated documentation is given, but, if this happen, it would in my opinion be in exceptions.
 

dgrainger

Trusted Information Resource
#7
There was a short transitional period for Rev 3.

"These guidelines incorporate changes introduced by Directive 2007/47/EC amending Council Directive 90/385/EEC and Council Directive 93/42/EEC and will be applicable as of 21st March 2010. The transitional period allowing a gradual implementation of the guidelines will therefore end on 20 March 2010."
 

Ronen E

Problem Solver
Staff member
Moderator
#8
There was a short transitional period for Rev 3.

"These guidelines incorporate changes introduced by Directive 2007/47/EC amending Council Directive 90/385/EEC and Council Directive 93/42/EEC and will be applicable as of 21st March 2010. The transitional period allowing a gradual implementation of the guidelines will therefore end on 20 March 2010."
That was the transition for 2007/47/EC. This time there's no change (yet) in the directive.
 
Thread starter Similar threads Forum Replies Date
M UDI transition period and implementation EU Medical Device Regulations 6
Ronen E Informational ISO 13485:2016 Transition Period End - 1 March 2019 ISO 13485:2016 - Medical Device Quality Management Systems 0
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
N Putting a new IVD on the market during the transition period EU Medical Device Regulations 4
Pmarszal UDI (Unique Device Identification) Transition Period - Packaging Labeling Other US Medical Device Regulations 5
thisby_ IEC 60601-1 3rd edition Transition Period - US vs. Europe US Food and Drug Administration (FDA) 5
T Transition Period of IEC EN 60601-2-37 IEC 60601 - Medical Electrical Equipment Safety Standards Series 9
B Implementation Schedule in EU for ISO 10993-7:2008 - Transition period? EU Medical Device Regulations 9
D When New Forms are Released, Should a Form Transition Period be Allowed? Document Control Systems, Procedures, Forms and Templates 13
T Brexit Transition Arrangements & Import into the EU EU Medical Device Regulations 3
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 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
T MDR Guidance Book - Useful for MDR transition? EU Medical Device Regulations 1
M Medical Device News EU – Transition Timelines from the Directives to the Regulations – Medical Devices and in vitro Diagnostic Medical Devices Medical Device and FDA Regulations and Standards News 13
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
qualprod 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, NADCAP and Aerospace related 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, NADCAP and Aerospace related 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, NADCAP and Aerospace related 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, NADCAP and Aerospace related 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, NADCAP and Aerospace related Standards and Requirements 3

Similar threads

Top Bottom