MDR

#1
Hi,

I have a few questions about an accessory to a medical device: (We do not manufacture the medical device, only the accessory

1. Does an accessory to a medical device has to carry the same classification? What if the medical device is a class I and the accessory emits energy? (Rule 9)?
2. Does the accessory have to comply with all the MDR requirement similarly to a medical device? If yes, how do you support clinical benefits without the actual device?
3. Is there a guidance document for that?

Thanks
Keren
 
Elsmar Forum Sponsor

Junn1992

Quite Involved in Discussions
#2
1. Does an accessory to a medical device has to carry the same classification?
No, accessory and medical device can be classified under different rules. But, the entire system itself would adopt the highest level classification of any of the parts.

What if the medical device is a class I and the accessory emits energy? (Rule 9)?
Just classify your accessory accordingly. The medical device system (which includes your accessory) that eventually reaches the market will adopt the highest class of any of the parts.

Does the accessory have to comply with all the MDR requirement similarly to a medical device? If yes, how do you support clinical benefits without the actual device?
Yes, because accessories are regulated as devices under the MDR.

The accessory intended use will state that this is to be used with certain type of devices.

As such, in and of itself, the accessory is unable to achieve any intended clinical benefit. Could your provide a more specific example of your accessory?
 

Ronen E

Problem Solver
Moderator
#3
1. Does an accessory to a medical device has to carry the same classification?
Not at all.
2. Does the accessory have to comply with all the MDR requirement similarly to a medical device?
Yes.
how do you support clinical benefits without the actual device?
The topic of clinical benefits is tricky, and is about as clear as mud :)
A BSI clinical reviewer told us that some medical devices do not have Clinical Benefits.

If you want more help with this I will have to work with you closely, to understand the situation with more certainty and see what can be done. Please send me a private message and we can take it from there (there may be confidentiality issues continuing the discussion in the public space).

בכל מקרה, בהצלחה
 

dgrainger

Trusted Information Resource
#4
Is it an actual "accessory for a medical device" or just something that is used with a device?

Do check the definition:
"means an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s);"
 
Thread starter Similar threads Forum Replies Date
J TGA CER & EU MDR CER Requirements for Australia Other Medical Device Regulations World-Wide 0
G MDR DRAFT DoC EU Medical Device Regulations 5
Z Classification according to MDR EU Medical Device Regulations 0
F MDR Distributor EU Medical Device Regulations 5
Y EU MDR Technical Documentation - Defined Review EU Medical Device Regulations 1
A Class 2b medical device - best pathway to obtain CE mark? (2022, MDR 2017/745) CE Marking (Conformité Européene) / CB Scheme 2
M Declaration of conformity MDR EU Medical Device Regulations 10
dgrainger Informational Manual on Borderline for MDR/IVDMDR EU Medical Device Regulations 6
G MDR Requirements for Samples EU Medical Device Regulations 5
C Applicability of classification rule 9 under MDR EU Medical Device Regulations 6
H Is testing according to IEC 60601-1 & IEC 60601-1-2 mandatory for a device being registered under MDR? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
Ed Panek MDR question - Meaning of Stability CE Marking (Conformité Européene) / CB Scheme 6
P Self Certified Class 1 MDR 2017/745 Design Change CE Marking (Conformité Européene) / CB Scheme 2
A EU MDR Annex II and Annex III CE Marking (Conformité Européene) / CB Scheme 6
N MDR requirments EU Medical Device Regulations 0
O MDD products under MDR certificate EU Medical Device Regulations 12
I Where to find MDR compliance device? EU Medical Device Regulations 6
J Conformity assessment route options under the UK MDR 2002 (2002 SI No. 618), as amended UK Medical Device Regulations 1
C Clinical Trial using Prototype devices (EU MDR & ISO 14155) EU Medical Device Regulations 4
M MDR Legal requirements EU Medical Device Regulations 6
Ed Panek MDR Audit Comment EU Medical Device Regulations 9
J Minor / Major findings with MDR EU Medical Device Regulations 4
R MDR Clinical Evaluation Plan EU Medical Device Regulations 6
R EU MDR Article 22 applicability of medical device with components. EU Medical Device Regulations 4
K Qualified MDR internal auditor? EU Medical Device Regulations 8
J Clinical Evaluation For Instruments - Class I, Class Ir, Class Im, and Class IIa - EU MDR EU Medical Device Regulations 4
G MDR Translation Requirements in Member States EU Medical Device Regulations 8
R General Obligations of Importers under EU MDR EU Medical Device Regulations 2
V MDR – Article 65 – Clinical investigations on minors EU Medical Device Regulations 6
I MDR Audit: NC per MDR Annex IX Administrative provisions 8. EU Medical Device Regulations 6
R Device with WiFi communication - EU MDR vs. EU RED EU Medical Device Regulations 2
L Clinical Evaluation MDR EU Medical Device Regulations 15
J Common Specifications per MDR EU Medical Device Regulations 2
L Looking for SOP Template for UDI under MDR EU Medical Device Regulations 4
P MDR Article 27 - UDI - Keeping records of UDIs EU Medical Device Regulations 1
Q Class I Medical Device with measuring function (UK MDR 2002 / MDD) UK Medical Device Regulations 3
F EU MDR Quality Plan template CE Marking (Conformité Européene) / CB Scheme 3
B Clinical Investigation in Denmark for MDR EU Medical Device Regulations 2
R EU MDR Remote vs In-Person Audit EU Medical Device Regulations 1
H IVDR & MDR CE Marking (Conformité Européene) / CB Scheme 6
H Update to UK MDR 2002 No. 618 UK Medical Device Regulations 2
A MDR article 54(2) "modifying" EU Medical Device Regulations 1
K MDD to MDR Other Medical Device and Orthopedic Related Topics 4
S EU MDR-Replacement Parts when not manufacture is not yet EU MDR compliant US Medical Device Regulations 2
dgrainger Informational Consolidated UK MDR 2002 UK Medical Device Regulations 0
E MDR Labelling & Languages EU Medical Device Regulations 2
K Subcontractors Providing Services Under MDD or MDR need ISO 13485 from EU Notified Body? CE Marking (Conformité Européene) / CB Scheme 8
D MDR: Active medical device or not? Medical Information Technology, Medical Software and Health Informatics 14
T Justification of use of non-harmonized standards for MDR conformity Other Medical Device Related Standards 12
F The meaning of MDR Article 61 6(b) EU Medical Device Regulations 1

Similar threads

Top Bottom