MDD Class I Medical Device Self Declaration Articles/Supplementary Documents

N

nurhakim

Hi Cove,

Good day to all!:bigwave:
Are there any specific MDD documents/articles/supplementary documents mentioning about self declaration of Class I medical device. Our product is non-sterile, non-measuring function.

Thanks all!
 

Ronen E

Problem Solver
Moderator
Please refer to that thread, starting from post #6. Post #7 has an attachment that might be what you were after. Other posts in that thread might interest you as well.

Cheers,
Ronen.
 
Last edited:
Thread starter Similar threads Forum Replies Date
Q Class I Medical Device with measuring function (UK MDR 2002 / MDD) UK Medical Device Regulations 3
Fjalar Spare parts for discontinued MDD compliant class I medical device EU Medical Device Regulations 4
H MDD Article 12 Labeling for Class IIa Medical Device - Please Advise EU Medical Device Regulations 3
A Class medical device (MDD) - Classification help EU Medical Device Regulations 1
W CE Mark for Class III Medical Device - MDR or MDD applies? CE Marking (Conformité Européene) / CB Scheme 10
R Class I Medical Device will be Class IIa after new MDD EU Medical Device Regulations 3
B Bangladesh Class IIA Medical Device MDD Registration Requirements Other Medical Device Regulations World-Wide 6
B Certificate of Exportability of Class IIA (EU MDD) Medical Device US Food and Drug Administration (FDA) 1
B What MDD (Medical Device Directive) Annex to follow for Class I device? EU Medical Device Regulations 14
somashekar Multisite CE certificate - Class IIB medical devices per MDD Annex 2 EU Medical Device Regulations 4
L Containment Device Classification - Class I Medical Device via Rule 1 MDD Annex IX EU Medical Device Regulations 1
S Technical File Review to updated MDD 93/42/EC (Class II medical devices) EU Medical Device Regulations 3
T Calculating Basic Risk/ Basic on Risk Analysis - Medical device MDD Class II and up ISO 13485:2016 - Medical Device Quality Management Systems 8
T European MDD Classification of Medical Devices (Risk Class) EU Medical Device Regulations 15
V CE Marking for Power Supply for Medical Device - Class IIb device per MDD, Rule 11 EU Medical Device Regulations 3
H Regulation in Australia - Importing medical device (class IIa as per MDD 93/42/EEC) ISO 13485:2016 - Medical Device Quality Management Systems 3
A PMSR or PSUR for legacy MDD-class I becoming MDR class-IIa EU Medical Device Regulations 8
L Class I under MDD EU Medical Device Regulations 1
P Servicing of Class IIb devices under MDD EU Medical Device Regulations 2
M MD Class I transition period MDD to MDR - changes? EU Medical Device Regulations 1
A First CE-mark class III implantable device under MDD EU Medical Device Regulations 8
S Until when can we CE-mark and sell MDD class 1 devices? CE Marking (Conformité Européene) / CB Scheme 23
K EU MDD Class I Device market access / certification after 26th May 2020 EU Medical Device Regulations 9
F Class I Device under MDD, reclassified to Class II under MDR Other Medical Device Related Standards 5
I MDD Class I software technical documentation sample EU Medical Device Regulations 2
M MDD 93/42/EEC, Annex IX - Class IIa vs IIb: "Potentially Hazardous" definition EU Medical Device Regulations 2
E CE MDD 93/42/EEC Class I Technical File Help CE Marking (Conformité Européene) / CB Scheme 4
S Spanish Customs Claim: Has the MDD class to be mentioned in the DoC? EU Medical Device Regulations 5
J MDD 93/42/EEC and Leather - CE-marking our (class I) product EU Medical Device Regulations 2
J MDD Class III Exclusions EU Medical Device Regulations 2
S MDD class IIa Annex V or VI: specific doubts when implented ISO 13485:2016 - Medical Device Quality Management Systems 6
S NCR under MDD - No documented procedure for class I device registration mechanism ISO 13485:2016 - Medical Device Quality Management Systems 2
K MDD Certification Ending EU Medical Device Regulations 1
S MDD Certificate extension according to 2023/67 MDR extension EU Medical Device Regulations 3
A MDD certificate expiration EU Medical Device Regulations 4
S Class1device - MDD extension EU Medical Device Regulations 2
A MDD Extension - certificate expiry CE Marking (Conformité Européene) / CB Scheme 4
H LM Transfer and MDD products in Supply chain ISO 13485:2016 - Medical Device Quality Management Systems 0
S Possible termination of MDD Certificate CE Marking (Conformité Européene) / CB Scheme 4
S MDD CE Marking & UKCA Marking UK Medical Device Regulations 2
K Sales of MDD devices with expired CE that are pending MDR certification EU Medical Device Regulations 4
O MDD products under MDR certificate EU Medical Device Regulations 12
K MDD to MDR Other Medical Device and Orthopedic Related Topics 4
K Subcontractors Providing Services Under MDD or MDR need ISO 13485 from EU Notified Body? CE Marking (Conformité Européene) / CB Scheme 8
K Selling legacy device under MDD to India EU Medical Device Regulations 1
G Updating MDD devices after MDR transitional period EU Medical Device Regulations 0
G Significant changes on MDD devices/Old Devices after MDR transitional period EU Medical Device Regulations 2
S Changing PCB Assembler and impact on QMS and MDD CE Certificate EU Medical Device Regulations 2
Ed Panek Auditor Comment about MDR vs MDD EU Medical Device Regulations 10
O MDD 93/42 and making documentation available EU Medical Device Regulations 1

Similar threads

Top Bottom