Class medical device (MDD) - Classification help

A

Aleksandra Sorokina

Registered
#1
#1
Our device is referred to IIb class (Rule 10 annex IX) in accordance with MDD 93/42. Some third-party accessories included in the delivery set of our device are referred to class III (Rule 6,7,8) annex IX) in accordance with MDD 93/42. The device is not surgically invasive.
1. Is it possible to refer the system to IIb class, if some of its accessories are referred to III class?
 
GAGEpack - Gage & Calibration Management
Elsmar Forum Sponsor
Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#2
#2
Aleksandra Sorokina said:
Our device is referred to IIb class (Rule 10 annex IX) in accordance with MDD 93/42. Some third-party accessories included in the delivery set of our device are referred to class III (Rule 6,7,8) annex IX) in accordance with MDD 93/42. The device is not surgically invasive.
1. Is it possible to refer the system to IIb class, if some of its accessories are referred to III class?
Click to expand...
Before this question can be answered, it's crucial to clarify beyond any doubt the sales configuration:
"Some third-party accessories included in the delivery set of our device"
This can be either
- A logistics arrangement, where several different and separate products are shipped together (commercially);
- A System or Procedure Pack as defined in the MDD Article 12; or
- A single medical device (what you refer to as "the system"), comprised of your device and the third-party accessories.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
T FDA UDI Question - Class II Medical Device Other US Medical Device Regulations 1
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
Fjalar Spare parts for discontinued MDD compliant class I medical device EU Medical Device Regulations 4
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
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
A ISO 13485 for Class 1 Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 7
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
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
Edward Reesor EU Authorized Representative for a Class I Medical Device CE Marking (Conformité Européene) / CB Scheme 11
W Direct to customer export of medical device (class I: prescription lenses + frame) US Food and Drug Administration (FDA) 2
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
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
M Notified Body audits -Class Ia medical device product EU Medical Device Regulations 4
N Can a (class I) medical device be manufactured in a GMP certified site with no ISO13485? EU Medical Device Regulations 18
U Do we need clinical trial data for Class IIa medical device under MDR EU Medical Device Regulations 7
R Countries that accept 510k approvals - Class II nonsterile medical device Other Medical Device Regulations World-Wide 2
B Class III Medical Device Accelerated conditions Other Medical Device Related Standards 1
D FDA Approved Class II Medical Device? Other US Medical Device Regulations 11
N CE Mark for Class 1 medical device CE Marking (Conformité Européene) / CB Scheme 11
D Class II medical device - When should a complaint be closed? Customer Complaints 6
D Software as an accessory to a Class I medical device EU Medical Device Regulations 4
C ETO Sterilised Class II Medical Device - Required Temperature Storage ISO 13485:2016 - Medical Device Quality Management Systems 1
A Does Class 1 Medical Device need to be certified to MDSAP? Canada Medical Device Regulations 5
N Can we take a part from 510k cleared medical device and use it in class I device? Other US Medical Device Regulations 3
J Class 1 Medical Device - Using a UPC over the UDI? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
N Selling a class II Medical Device in Canada in Pharmacies Elsmar Xenforo Forum Software Instructions and Help 10
S Acrylic in Class II b Active Medical Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
L A Taiwan company want to sell Class I medical device (510(k) exempt) on Amazon, should we register with FDA? US Food and Drug Administration (FDA) 4
S Conformity Assessment Route question for Class IIa medical device under MDR EU Medical Device Regulations 3
K Inventory Control - Class II (IIb for CE) medical device ISO 13485:2016 - Medical Device Quality Management Systems 6
S Software Release Note - Class A stand alone software medical device IEC 62304 - Medical Device Software Life Cycle Processes 2
J FDA Class 1 Medical Device UDI requirements Other US Medical Device Regulations 19
L Class IIa Medical Device, CE Mark & 510k - Labeling Content CE Marking (Conformité Européene) / CB Scheme 4
M How is Class I Medical Device Compliance Enforced? EU Medical Device Regulations 7
K Calibration of Dose Area Product (DAP) Meter in our Class IIb X-Ray Medical Device General Measurement Device and Calibration Topics 1
Z Class 2 medical device - Process Validation - Test sterile or non-sterile units? Qualification and Validation (including 21 CFR Part 11) 4
C Medical device manufacturing (class 2 ISO 13485:2016) - Is a Deviation allowed? Other Medical Device Related Standards 5
S Understanding UDI requirements - Class 2 medical device (hearing aids) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3

Similar threads

Top Bottom