MDR GSPR Clause 17 - Software Requirements

Sue789

Involved In Discussions
#1
I am buying an off the shelf joystick and download the manufacturers software we make no change to either part. Would section 17 to 17.4 be applicable?
This is the only software in the Class I medical device. I am now begging to think it is not applicable what are your thoughts?
 
Elsmar Forum Sponsor

shimonv

Trusted Information Resource
#2
Hi Sue789,
The requirements in GSPR clause 17 are mostly about software, weather you develop it yourself or buy it as an off-the-shelf component.
The joystick & software are now a part of your medical device, and you need to demonstrate it's safety and effectiveness. At the very least you need to do some software / system testings and update the risk management file.

Good luck,
Shimon
 

Sue789

Involved In Discussions
#3
Hi Sue789,
The requirements in GSPR clause 17 are mostly about software, weather you develop it yourself or buy it as an off-the-shelf component.
The joystick & software are now a part of your medical device, and you need to demonstrate it's safety and effectiveness. At the very least you need to do some software / system testings and update the risk management file.

Good luck,
Shimon
Thank you very much with your quick response this was my initial thought
 
Thread starter Similar threads Forum Replies Date
F MDR GSPR Checklist template EU Medical Device Regulations 4
A MDR GSPR Checklist wanted EU Medical Device Regulations 3
Rincewind MDR - GSPR - Annex I - Chapter II EU Medical Device Regulations 2
M MDR - Is a formal GSPR Procedure required? EU Medical Device Regulations 20
D Summary of safety and clinical performance in GSPR MDR EU Medical Device Regulations 2
E EU MDR GSPR 23.1 information on website CE Marking (Conformité Européene) / CB Scheme 2
S Converting SOP MDD to MDR Noob ISO 13485:2016 - Medical Device Quality Management Systems 3
K Biological indicator system classification under MDR EU Medical Device Regulations 0
L 'Distributor' definition & MDR/MSR relationship EU Medical Device Regulations 0
A What does this line from MDCG 2020-3 (MDR art. 120 substantial change) mean to you? EU Medical Device Regulations 0
J EU MDR getting closer - Special offer for Elsmar members 10/2020 EU Medical Device Regulations 8
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 1
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
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
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
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 MDR Delay - MDD design Change? (before new MDR DOA) EU Medical Device Regulations 8
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
B FDA-Medical Device Reporting (MDR )procedure compliant with 21CFR section 803 US Food and Drug Administration (FDA) 0
J PPE, the MDR and EU 2016/425 EU Medical Device Regulations 4

Similar threads

Top Bottom