Former Class I device that is upscaled to IIa if the MDR is delayed

#1
Hello everyone. I hope you are all healthy and doing well. I have a question.

If the extension for applying the MDR takes place, a former Class I device that is upscaled to IIa (when passing from MDD to MDR) can be on the market until 2024 if it has a DoC (under the MDD) and doesn't have significant changes on the intended purpose, follows market and PMS, vigilance, registers EOs as for the MDR.

My question is: the application of DoC for these devices is May 2020 or May 2021? Thanks in advance!
 
Elsmar Forum Sponsor

mihzago

Trusted Information Resource
#2
it's May 2021. See below. More details in Erik's blog if you're interested: MDR amendment proposal article 120 (3) oversight set to be fixed by Council

Article 1 6) (aa)Article 120 is amended as follows:

paragraph 3 is replaced by the following:

“By way of derogation from Article 5 of this Regulation, a device which is a class I device pursuant to Directive 93/42/EEC, for which the declaration of conformity was drawn up prior to 26 May 2021 and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body, or which has a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and that is valid by virtue of paragraph 2 of this Article, may be placed on the market or put into service until 26 May 2024, provided that from 26 May 2021 it continues to comply with either of those Directives, and provided there are no significant changes in the design and intended purpose. However, the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives.,”
 
Thread starter Similar threads Forum Replies Date
BLoganB UDI for former manufacturer - My company is a distributor Other US Medical Device Regulations 0
supadrai Prop 65 - A (former) litigation attorney's (now in-house counsel at a MD manufacturer) perspective. RoHS, REACH, ELV, IMDS and Restricted Substances 18
J Looking for feedback from current/former Intelex users Quality Assurance and Compliance Software Tools and Solutions 4
P Regulations to Register Medical Devices in Republics of former Yugoslavia Other Medical Device Regulations World-Wide 2
J Taking over for former QA... Where to start? How to proceed? IATF 16949 - Automotive Quality Systems Standard 4
A "Do's" and "Don'ts" of auditing a former employer General Auditing Discussions 12
T Finding Suppliers for automotive industry in the former Yugoslavia countries Manufacturing and Related Processes 1
P Farewell Former President Cory Aquino World News 0
GStough What would you do? Former boss needs help General Auditing Discussions 39
R Analysis of Data - The former "Statistical Techniques" procedure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
shimonv Clinical evaluation report for class I device EU Medical Device Regulations 3
D Control Number for Class III and IV devices Canada Medical Device Regulations 0
M Class II type machine , and its compliance with 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 14
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
P ISO 14644 Class 8 Cleanroom Air Filter Requirements Other Medical Device Related Standards 4
J Instructions for use for Class I devices under MDR EU Medical Device Regulations 1
D Electrical Medical Devices class I EU Medical Device Regulations 0
K MDR Class 1 Self Certification - Competent Authority or Notified Body? EU Medical Device Regulations 6
K "World Class Product" based QM. I need advice. Quality Management System (QMS) Manuals 14
L Class IIb devices marked EC according to the 93/42/CE - Portugal CE Marking (Conformité Européene) / CB Scheme 3
J Biocompatbility testing on Class 1 device requirements Other US Medical Device Regulations 12
J Reusable surgical Instrument is under class IIa? EU Medical Device Regulations 4
H EU CE marking for Medical Device Class I EU Medical Device Regulations 2
E Any sample of a full software life cycle IEC 62304 report ( any class )? IEC 62304 - Medical Device Software Life Cycle Processes 1
JoCam Certified QMS for MDR - Class I medical device manufacturers EU Medical Device Regulations 4
N Is there a need for clinical test of Class IIa products (for MDR)? EU Medical Device Regulations 2
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
J IEC 60601-1-11 Home Class II With Ballasts IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
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
A AMSQQP416E Class 2 type 2 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
S IVD risk class II devices for Brazil and MDSAP Other Medical Device Regulations World-Wide 0
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
S Medical watch Class II (AP Type CF) with USB connection IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
L Radiology software Class I exemption Medical Device and FDA Regulations and Standards News 3
K CE Marking for Class I Medical Device? CE Marking (Conformité Européene) / CB Scheme 8
A Class I (exempt) testing requirements Other Medical Device Related Standards 0
Z Class I marketing regulation and supply chain Other Medical Device Regulations World-Wide 0
S We are looking for EU authorised Representative for both Class I and Class IIb devices EU Medical Device Regulations 7
S How is the service life for class I reusable medical devices described in MDR? EU Medical Device Regulations 7
S How is the service life described for class I reusable medical devices in MDR? Elsmar Xenforo Forum Software Instructions and Help 1
R Class 1 Convenience kits for home teeth impression, NOT smile direct or other for alignment purposes Canada Medical Device Regulations 0
J Confusing on Harmonic Emissions/Voltage Fluctuations/Flicker test for CISPR 11 Class A Equipment IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
J Intervertebral body fusion cage, MDR Class II or Class III? EU Medical Device Regulations 4
T Do I need a qualified compiler for class B software? IEC 62304 - Medical Device Software Life Cycle Processes 3
R Nanomaterials used as coating on class I MD - rule 19 EU Medical Device Regulations 4

Similar threads

Top Bottom