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?
 
Paper to QMS ad
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
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 2
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) 1
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
N Per the FDA regulations can a medical device be class I despite that it is sterile? Other Medical Device Related Standards 4
M Include IFU in Class II Medical Device Marketing Brochure? US Food and Drug Administration (FDA) 2
J Steps when changing material for class 1 medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Clinical evaluation for a class IIa medical device - EU MDR Requirements EU Medical Device Regulations 3
A Class I medical device and Category III PPE - Long length gloves EU Medical Device Regulations 5
B Manufacturing site relocation of pre amendment Class II medical device Manufacturing and Related Processes 4
S Class II Medical Device Conformity Assessment Route according to Annex V only CE Marking (Conformité Européene) / CB Scheme 7
H Classification of a Class IIb Medical Device with 3 Components CE Marking (Conformité Européene) / CB Scheme 1
J Class 1 Medical Device ECR (Engineering Change Request) Changes 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
W CE Mark for Class III Medical Device - MDR or MDD applies? CE Marking (Conformité Européene) / CB Scheme 10
C Pressure requirement of home based Class II Medical Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
A Technical file requirement for Class IIb medical device CE Marking (Conformité Européene) / CB Scheme 3
S Who needs a 510(k) in this situation? Class II medical device for a US Orthodontist Other US Medical Device Regulations 4
B How to certify a Class IIa Medical Device CE Marking (Conformité Européene) / CB Scheme 1
Similar threads
Top Bottom