Class I Device under MDD, reclassified to Class II under MDR

Frypot

Starting to get Involved
#1
We manufacture a device for a customer currently classed as a Class I, he has been informed by his NB that under the MDR it should be classified as a Class IIb device and he must re-register it as a Class II by 26 May 2020.
We're currently stock building (Brexit and all that!) my question is:
If it is currently a Class I, is this deadline because it needs to be re-classified under MDR or would it be allowable to sell as Class I (with the artwork unchanged from original) after the 'deadline.
My view was that it could continue to be sold as Class I until the MDD cert ran out... now I'm not so sure!
 
Elsmar Forum Sponsor

Frypot

Starting to get Involved
#3
No measuring function, non-sterile so CE declaration (by customer) not audited but they are ISO13485 certified.
Device is an olive oil spray for softening earwax.
 

Sullen-gent

Involved In Discussions
#4
That is very curious wonder what rule it has to be reclassified under?

No you couldn't sell this as a class I device once the MDD expires, as you have no directive to be in compliance with (as it is repealed). That's why you need to either be MDR compliant or covered by a notified certificate under MDD after MDD expiry.
 

Frypot

Starting to get Involved
#6
I made this note (can't remember source sorry) while doing some research:
The MDR provides that substance-based devices intended to be introduced into the human body via a body orifice or applied skin (Rule 21) may not be Class I. Consequently, substance-based devices currently in Class I will be up-classified and thus be subject to stricter requirements.

Obviously it is introduced via an orifice (the ear).
 
Thread starter Similar threads Forum Replies Date
A First CE-mark class III implantable device under MDD EU Medical Device Regulations 8
U Do we need clinical trial data for Class IIa medical device under MDR EU Medical Device Regulations 7
S Conformity Assessment Route question for Class IIa medical device under MDR EU Medical Device Regulations 3
Q 93/42/EEC Class I Medical Device Weigh Scale - Class A under EN 62304? IEC 62304 - Medical Device Software Life Cycle Processes 15
S NCR under MDD - No documented procedure for class I device registration mechanism ISO 13485:2016 - Medical Device Quality Management Systems 2
T FDA UDI Question - Class II Medical Device Other US Medical Device Regulations 1
CharlieUK EU representative details on Class I device CE Marking (Conformité Européene) / CB Scheme 3
A Class 1 medical device - Thailand Other Medical Device Regulations World-Wide 0
J Shoe Covers - medical device class I EU Medical Device Regulations 3
shimonv Can you submit a traditional application for a class I device? Other US Medical Device Regulations 7
Fjalar Spare parts for discontinued MDD compliant class I medical device EU Medical Device Regulations 4
M Issues with leakage current testing for a CLASS II device since no PE and FE is present IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
J Med Device Class for a Service Organization ISO 13485:2016 - Medical Device Quality Management Systems 2
shimonv Clinical evaluation report for class I device EU Medical Device Regulations 14
K Technical file for MHRA - looking for assistance with self declaration Class I device CE Marking (Conformité Européene) / CB Scheme 8
A Clinical assessment sample size - Medical device Class IIb implantable (93/42 directive) EU Medical Device Regulations 2
J Should a Class 1 medical device with an option to measure body weight be considered Class 1m? EU Medical Device Regulations 0
J Biocompatbility testing on Class 1 device requirements Other US Medical Device Regulations 12
H EU CE marking for Medical Device Class I EU Medical Device Regulations 2
JoCam Certified QMS for MDR - Class I medical device manufacturers EU Medical Device Regulations 8
K CE Marking Class 1 (Non sterile) medical device CE Marking (Conformité Européene) / CB Scheme 3
G Voluntary Class I Device Filing Other US Medical Device Regulations 4
A ISO 13485 for Class 1 Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 7
N Validating Software before getting approved as Class 2 device US Food and Drug Administration (FDA) 5
D Can a diagnostic device be class I? EU Medical Device Regulations 1
P Anyone have an Idea on UAE Medical device registeration- Class B with FDA only Other Medical Device Regulations World-Wide 0
F Mobile app regulations - Class II medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
K CE Marking for Class I Medical Device? CE Marking (Conformité Européene) / CB Scheme 8
D Class IIB Medical Device Accessories - OTS Tablets Other Medical Device Regulations World-Wide 1
K Doubt on insulation class of a device IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
F How to register class I device to all European Competent Autorities(CA) when we are European manufacturer EU Medical Device Regulations 4
K Sterile barrier system symbols - Label redlines for a Class III device (Kit Box) EU Medical Device Regulations 0
D Class 3 Device - Change of supplier of material Canada Medical Device Regulations 6
A Interpretation of GMP Requirements for class 1 medical device manufacturer (device GMP exempt, only General controls applicable) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
H MDD Article 12 Labeling for Class IIa Medical Device - Please Advise EU Medical Device Regulations 3
A Medical Device Vigilance decision tree for Japan for class 2 devices. Japan Medical Device Regulations 1
S Shipment of a CE Approved Class III Device to the EU Member States Other US Medical Device Regulations 1
Edward Reesor EU Authorized Representative for a Class I Medical Device CE Marking (Conformité Européene) / CB Scheme 11
dinaroxentool Former Class I device that is upscaled to IIa if the MDR is delayed EU Medical Device Regulations 2
W Direct to customer export of medical device (class I: prescription lenses + frame) US Food and Drug Administration (FDA) 2
M CE self-certification for Class I device (face mask) EU Medical Device Regulations 9
C New Class III medical device application for Health Canada Canada Medical Device Regulations 6
T First 510(k) submission - Class II software as medical device US Food and Drug Administration (FDA) 3
Y Retrospective Validation - Class I device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
JoCam Failure to test Class I medical device to IEC 60601-1-11 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
S How to register class IIA medical device accessories EU Medical Device Regulations 1
U Medical device trial budget - 2 hospitals for Class IIa medical device in Sweden Other Medical Device and Orthopedic Related Topics 2
A Class medical device (MDD) - Classification help EU Medical Device Regulations 1
M Changing supplier of critical raw material (III class device) Other Medical Device and Orthopedic Related Topics 1
M Notified Body audits -Class Ia medical device product EU Medical Device Regulations 4

Similar threads

Top Bottom