CE Mark for Standalone Medical Computer Monitoring Software

I

indorewalep

#1
Hello,


Subject : CE mark for standalone monitoring software.


Intended Use:


1. My Software will be used on IT equipment (Computer)
2. My Software will be used to monitor patient data (like central nursing station).
3. IT equipment (Computer) will be connected with Medical devices by an IT network.



Question 1: Whether my software is a medical Device ?

Question 2: If yes, then what is the classification for this medical device & applicable harmonized standards?
 
Elsmar Forum Sponsor

Stijloor

Staff member
Super Moderator
#2
Hello,


Subject : CE mark for standalone monitoring software.


Intended Use:


1. My Software will be used on IT equipment (Computer)
2. My Software will be used to monitor patient data (like central nursing station).
3. IT equipment (Computer) will be connected with Medical devices by an IT network.



Question 1: Whether my software is a medical Device ?

Question 2: If yes, then what is the classification for this medical device & applicable harmonized standards?
Bump!

Can someone help?

Thank you!!

Stijloor.
 
E

esalsan

#3
Definition of medical device can be found in the directive. Take the latest consolidated version of what is applicable to you: http://ec.europa.eu/health/medical-devices/regulatory-framework/legislation/index_en.htm

NOTE: accessories are also considered as devices and the medical device directive is applicable to them.

You can find guidance on the classification rules here.

The list of harmonized standards is updated every now and then: http://ec.europa.eu/enterprise/poli...ards-legislation/list-references/index_en.htm

"Monitoring of patient data" sounds likely to be a device, but further description will be required to understand your particular case, I am sure other covers will ask for more details.
 

c.mitch

Quite Involved in Discussions
#4
Hello,

To add info to answers of esalsan, software are active medical device and their classification is generally determined by using rules 9 to 12 of the annex IX of the EC directive.
Otherwise, if your software drives or influences a medical device then it falls into the same class as the medical device. The assessment of "drive" or "influence" is the main problem of this task. Each case is unique and only you have enough information, found especially in the intended use and user requirements, to assess it.

To answer question 2, and based on your description, one of the applicable harmonized standards is certainly EN 62304. There may be others, like EN 62366.

The list of harmonized standards is here:

Reminder: harmonized standard should be implemented on a voluntary basis by manufacturers.

Mitch.
www.cm-dm.com
 
D

doubetrucker

#5
We use Myjad keylogger. It reports back to a designated server that you set up on your internal network.

OSX can log applications by user but probably nit to the extent that you wish.
 
A

allencently

#6
Hello,


Subject : CE mark for standalone monitoring software.


Intended Use:


1. My Software will be used on IT equipment (Computer)
2. My Software will be used to monitor patient data (like central nursing station).
3. IT equipment (Computer) will be connected with Medical devices by an IT network.



Question 1: Whether my software is a medical Device ?

Question 2: If yes, then what is the classification for this medical device & applicable harmonized standards?
emergogroup.com/resources/articles/software-as-medical-device
This article will give you some adviece if this is a medical Device and which
Classification it is.
 
Thread starter Similar threads Forum Replies Date
V New Product Model CE Mark Certification under MDR EU Medical Device Regulations 0
P Violation of CE mark - Re-use of single-use Products CE Marking (Conformité Européene) / CB Scheme 2
K One CE Mark holder - multiple manufacturing sites EU Medical Device Regulations 3
A First CE-mark class III implantable device under MDD EU Medical Device Regulations 8
F List of countries that 'prefer' a CE Mark CE Marking (Conformité Européene) / CB Scheme 1
C Surgical mask stability testing (CE mark) EU Medical Device Regulations 2
M MDR EU Distributor for our CE Mark product in the for Netherlands EU Medical Device Regulations 6
D Does Manufacture can submit CE mark application under MDD with NB for his New product after May 2020? EU Medical Device Regulations 3
Ed Panek CE Mark Requirements on Kits (off the shelf product requirements met) CE Marking (Conformité Européene) / CB Scheme 2
R IVDR CE Mark for Class A products - Declaration of Conformity CE Marking (Conformité Européene) / CB Scheme 2
G UVC sterilizer CE Mark CE Marking (Conformité Européene) / CB Scheme 5
C Does a CE mark infer meeting all applicable standards? CE Marking (Conformité Européene) / CB Scheme 4
M CE Mark and 510(k) -Global registration requirements for every country Other Medical Device Regulations World-Wide 3
A CE Mark and PMCF study EU Medical Device Regulations 3
T CE mark start date for a device EU Medical Device Regulations 7
P API monogram mark requirements Oil and Gas Industry Standards and Regulations 1
S CE Mark - Classification Confusion EU Medical Device Regulations 12
S Until when can we CE-mark and sell MDD class 1 devices? CE Marking (Conformité Européene) / CB Scheme 17
N CE Mark for Class 1 medical device CE Marking (Conformité Européene) / CB Scheme 11
Y CE Mark - Placing the CE mark on medical device labels EU Medical Device Regulations 2
B Need For BIS Standard Mark? Imported OEM's Power supply,Li-Ion Battery Other Medical Device Regulations World-Wide 0
D Vietnam requirement of CE mark for medical devices CE Marking (Conformité Européene) / CB Scheme 4
A CE mark - Measuring Instruments Directive confusion! CE Marking (Conformité Européene) / CB Scheme 0
S CE mark on a medical device - Textile product CE Marking (Conformité Européene) / CB Scheme 2
V CE Mark under MDD or IVDR - IVD company doing Virtual Manufacturing Other Medical Device Regulations World-Wide 3
S REF and CE mark symbols on multi-component device EU Medical Device Regulations 3
D Who are the accredited Certified Bodies for CE Mark for Medical Devices? CE Marking (Conformité Européene) / CB Scheme 7
Ed Panek GTIN (Global Trade Item Number) for non CE Mark Other Medical Device Related Standards 4
S Can we still manufacture whilst awaiting return of our CE Mark? Other Medical Device Related Standards 1
J EC REP information and CE Mark - Component of a system that is not a medical device EU Medical Device Regulations 2
F Interpretation of MDR 2017/745 Article 23 - CE Mark Requirements EU Medical Device Regulations 8
C Is CE Mark needed for a small DAC audio board on top of a Rasberry PI? CE Marking (Conformité Européene) / CB Scheme 1
B Do CE Mark associations exist? CE Marking (Conformité Européene) / CB Scheme 1
E EU Class 1s CE Mark Regulatory Pathway EU Medical Device Regulations 9
K CE mark transition and new regulations CE Marking (Conformité Européene) / CB Scheme 0
L Class IIa Medical Device, CE Mark & 510k - Labeling Content CE Marking (Conformité Européene) / CB Scheme 4
R List of countries that require only CE Mark certificate for product registration Other ISO and International Standards and European Regulations 2
Ronen E RIP Mark Hollis 1955-2019 Coffee Break and Water Cooler Discussions 0
M CE mark validity after Brexit, 29th March '19 EU Medical Device Regulations 6
M Start-Up Company looking for ISO 13485 Certification Body and Medical Device CE Mark Notified Body Registrars and Notified Bodies 6
A CE Mark PPE Category III for our customers residing in the EU CE Marking (Conformité Européene) / CB Scheme 1
H Can an OEM use an CM ISO 13485 certification in helping to get out CE Mark? ISO 13485:2016 - Medical Device Quality Management Systems 2
S CE ETA (A2) Audit - CE mark for the european construction market CE Marking (Conformité Européene) / CB Scheme 0
W CE Mark for Class III Medical Device - MDR or MDD applies? CE Marking (Conformité Européene) / CB Scheme 10
D US Made class I CE Mark product for export only to EU Other US Medical Device Regulations 4
M ISO 13485 Required for CE Mark on Class I product CE Marking (Conformité Européene) / CB Scheme 1
O Private label issues For EU - Customer does not have CE Mark CE Marking (Conformité Européene) / CB Scheme 7
C Addition of Design & Manufacture - CE Mark Reissue? EU Medical Device Regulations 1
I IEC 60601 and the UL mark 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
D CE Mark with same NB (Notified Body)? CE Marking (Conformité Européene) / CB Scheme 4

Similar threads

Top Bottom