MDR Delay - MDD design Change? (before new MDR DOA)

Sammy23

Starting to get Involved
#1
With the MDR delayed until May 2021, are able to make a design change to our MDD compliant device? We have a design change project, where all V&V and necessary documentation will be completed by May 2020. Based on Article 120 (3), since the DOA is now May 2021, can we make this design change? Is Article 120(3) saying that we can make design changes to MDD compliant devices prior to the DOA?

Article 120(3)

"By way of derogation from Article 5 of this Regulation, a device with a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and which is valid by virtue of paragraph 2 of this Article may only be placed on the market or put into service provided that from the date of application of this Regulation 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."
 
Elsmar Forum Sponsor

Asia78

Involved In Discussions
#7
Yes, you can make significant changes to mdd devices until may 2021.
The new DoA implies also the postponment of all the applicable requirements.
The published MDCG guidances are still valid in their content, but the dates written may be wrong being that they were published before the latest changes to the Mdr
 

Philip B

Involved In Discussions
#8
BSi stopped clients making significant changes to their MDD certificates last year as there would not have been enough time to implement these before May 2020. Not sure what their stance is now the MDR has been put back a year? Best to check with your NB.
 
Thread starter Similar threads Forum Replies Date
M Informational From RAPS – EU MDR/IVDR: US Raises ‘Serious Concerns,’ Urges 3-Year Implementation Delay Medical Device and FDA Regulations and Standards News 3
E Our company is planning to file MDD not MDR next month. Do we require to show chemical characterization report ? CE Marking (Conformité Européene) / CB Scheme 1
S Classification of a product according to MDR EU Medical Device Regulations 3
L Classification under MDR EU Medical Device Regulations 1
I Interpretation of the MDR GSPR 23.4 (u) EU Medical Device Regulations 2
S Converting SOP MDD to MDR Noob ISO 13485:2016 - Medical Device Quality Management Systems 4
K Biological indicator system classification under MDR EU Medical Device Regulations 2
L 'Distributor' definition & MDR/MSR relationship EU Medical Device Regulations 1
A What does this line from MDCG 2020-3 (MDR art. 120 substantial change) mean to you? EU Medical Device Regulations 3
J EU MDR getting closer - Special offer for Elsmar members 10/2020 EU Medical Device Regulations 11
D ISO 14971:2019 vs MDR Annex 1, Requirement #4 - "Manufacturers shall inform users of any residual risks" ISO 14971 - Medical Device Risk Management 2
G MDR translation requirements EU Medical Device Regulations 3
K Applicability of Cybersecurity EU MDR 2017/745 Annex 1 23.4(ab), 14.2(d) CE Marking (Conformité Européene) / CB Scheme 3
K Applicability of eIFU as per EU MDR 2017/745 Annex 1 23.1 CE Marking (Conformité Européene) / CB Scheme 0
rob73 UK Medical Device Regulations Forum - UK MDR Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 1
J Intervertebral body fusion cage, MDR Class II or Class III? EU Medical Device Regulations 4
F MDR GSPR Checklist template EU Medical Device Regulations 4
B Clinical Evaluation Expert Panels - MDR EU Medical Device Regulations 1
M EU MDR - Labilities when a device is discontinued from the Market EU Medical Device Regulations 1
S National registrations for MDR certified devices in absence of EUDAMED EU Medical Device Regulations 2
Z MDR Class Ir deadline (Reusable surgical instruments) EU Medical Device Regulations 27
B MDR equvalent device - can you use a medicine as an equivalent 'device' EU Medical Device Regulations 8
N Harmonized Standards for MDR Certification EU Medical Device Regulations 7
K Is UDI (Unique Device Identifier) symbol mandatory under EU MDR? EU Medical Device Regulations 1
K EU MDR Annex 1 Chapter III: Information in the Instructions for Use-23.4 (e) the performance characteristics of the device; EU Medical Device Regulations 1
R Requirements for MDR Article 22 Systems EU Medical Device Regulations 1
H EU MDR Economic Operator notifications? EU Medical Device Regulations 1
M MDR EU Distributor for our CE Mark product in the for Netherlands EU Medical Device Regulations 6
R Declaration of conformity as per EU MDR (2017/745) CE Marking (Conformité Européene) / CB Scheme 5
K Class III Kit Box - Are translations mandatory under EU MDR? EU Medical Device Regulations 5
B Herbal ingredients MDR EU Medical Device Regulations 0
S MDR GSPR Clause 17 - Software Requirements EU Medical Device Regulations 2
N Which EN ISO 17664 version compliance to EU MDR? Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 3
D Hospital Decontamination and the MDR - Technical Files, UDI and PMS EU Medical Device Regulations 3
K Submission of MDR File - Partner Companies - Computed Tomography (CT) CE Marking (Conformité Européene) / CB Scheme 10
B How to classify a medical device based on MDR? EU Medical Device Regulations 3
A MDR GSPR Checklist wanted EU Medical Device Regulations 6
Rincewind MDR - GSPR - Annex I - Chapter II EU Medical Device Regulations 2
N EU MDR - Applicability Article 22 Systems and Procedure Packs CE Marking (Conformité Européene) / CB Scheme 4
B EU MDR Perscription product guidance EU Medical Device Regulations 1
cscalise Suggestions for MDR Auditing tools EU Medical Device Regulations 1
M Example of statement for procedure pack MDR Article 22? Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 0
H MDD CM, MDR manufacturer. 2020. Is it ok? EU Medical Device Regulations 1
M MDR, RED and LVD - Should our device comply with them? EU Medical Device Regulations 2
E UK MDR brexit out of sync with EU MDR deadline? UK Medical Device Regulations 4
S Class I MDR Article 10 – QMS EU Medical Device Regulations 1
dgrainger Medical Device News MDR postponed - link to Official Journal of the European Union (24-4-2020) EU Medical Device Regulations 2
K Supply Agreement Regarding MDR 2017/745 - Manufacturer-supplier cooperation Other Medical Device Related Standards 0
Ed Panek Medical Device News MDR Delayed 1 year (Posted 4/2020) EU Medical Device Regulations 9
dinaroxentool Former Class I device that is upscaled to IIa if the MDR is delayed EU Medical Device Regulations 2

Similar threads

Top Bottom