Refurbishing of Class2a Medical Devices

P

patmelad

Starting to get Involved
#1
#1
We currently have a CE marked class 2a Medical Device, Reusable, Not Sterile, Never had an incident or recall. This product was introduced to the market in 1992.

From 1992 to 2010 We had VDE approval .
From 2011 until present we have had CE approval This was a slightly different model But all electronics software wiring plastic are identical .Just a slight mechanical difference.

What we are looking to do is Refurbish existing VDE approved older equipment up to the Current Standard For CE , and then reintroduce this equipment back into the market under a new model . The intended use usability risk management of the Refurbished Model is identical to the equipment currently being used that is CE approved .

Is there any clear way to do this or guidelines on how to do this, and probably the most important question is can we do this?

Any insight would be appreciated!!
 
Download Free White Paper
Elsmar Forum Sponsor
M

Mark Meer

Trusted Information Resource
#3
#3
patmelad said:
...Is there any clear way to do this or guidelines on how to do this, and probably the most important question is can we do this!
Click to expand...
In short, you can do this. A couple suggestions, however:

- Treat it like rework (taking non-conforming product, and making it conforming), and hence subject to whatever procedure you have for rework (impact/risk assessment, approved rework instructions/procedure, acceptance criteria, record keeping...).

- You should (must?) disclose that the resulting product is not new. It can be marketed as "refurbished", "restored",whatever...and sold at discount. But to sell the device along with your brand-new inventory could be considered deceptive marketing.
 
P

patmelad

Starting to get Involved
#4
#4
Thank you Mark for your reply, I just had my surveillance audit for CE and our transition audit for upgrading to 13485:2016. Zero non conformance I am proud to say.
I know that the New MDR 2017/745 Deals much more directly with Refurbished Medical devices. I have already started to pull together a Technical File for the product and being that this is all so new there is not much help to be found on where to start. I am a one man Department here , just trying to find whatever help I can. If you have any other insights on this matter I would be very interested to hear them.
Thanks again
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
G Fully refurbishing process EU Medical Device Regulations 3
F Reprocessing or refurbishing? Single Use Medical Device CE Marking (Conformité Européene) / CB Scheme 0
Q Guidance regarding Legally Refurbishing a Non-RoHS Instrument in the EU REACH and RoHS Conversations 1
M Refurbishing a Medical Device - Any additional information needed 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Q Remanufacturing and Refurbishing of Class 1 Medical Devices - Process Question ISO 13485:2016 - Medical Device Quality Management Systems 8
B Generic procedure for repair / refurbishing / rework modifications to PCB components Document Control Systems, Procedures, Forms and Templates 3
U Does Medical Device training video falls under labeling requirement ? Other US Medical Device Regulations 4
dgrainger Informational Consultation: Medical devices – single identifier for similar highly individualised devices EU Medical Device Regulations 0
dgrainger Informational MHRA Guidance: Crafting an intended purpose in the context of Software as a Medical Device (SaMD) UK Medical Device Regulations 0
J Is ISO 13485 certification necessary for Class I (non-sterile) medical devices? ISO 13485:2016 - Medical Device Quality Management Systems 4
L Directive 2012/19/EU for medical software EU Medical Device Regulations 2
S Sample size considerations in medical process qualification Reliability Analysis - Predictions, Testing and Standards 11
B Medical device disposables - Stored in a controlled environment for 4 months - Effects on Sterilization Medical Device and FDA Regulations and Standards News 1
W MOOPs in Medical Device Charger IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
S Specification (Significant digits) - Measurement (Medical device) ISO 13485:2016 - Medical Device Quality Management Systems 3
S Accessory to medical device or not? EU Medical Device Regulations 1
M Looking for medical grade wall adapter with 50Hz power transformer IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
E Microbial Barrier Testing for Medical Devices Qualification and Validation (including 21 CFR Part 11) 2
R Medical equipment selection for refurbishment US Food and Drug Administration (FDA) 1
E Sealing Validation for Medical devices Qualification and Validation (including 21 CFR Part 11) 5
K Question on registration of class 1 medical device in Turkey Other Medical Device Regulations World-Wide 0
A Safety testing of Medical devices ISO 13485:2016 - Medical Device Quality Management Systems 2
A Safety testing for Medical devices to be sold in India ISO 13485:2016 - Medical Device Quality Management Systems 0
G China registration update medical devices China Medical Device Regulations 3
N Class II Medical Device with Metallic Enclosure IEC 60601 - Medical Electrical Equipment Safety Standards Series 11
S Export of CE marked medical devices outside of Europe EU Medical Device Regulations 1
D Swiss Documentation Requirements for Class 1 Medical Device Other Medical Device Related Standards 0
A Medical Device including a smartphone - CE mark ? CE Marking (Conformité Européene) / CB Scheme 4
C VOCs as extractable in substance based medical device EU Medical Device Regulations 0
D Correct form to amend medical devices class III (IMDRF vs Form 2016) Canada Medical Device Regulations 0
M Servicing Medical Lasers IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
S Mexico medical device registration - for demo Other Medical Device Regulations World-Wide 1
R Gibraltar refurbished medical devices UK Medical Device Regulations 1
L Use of Medical grade plastics in medical devices EU Medical Device Regulations 3
M Medical Devices Regulations and labelling requirements UAE Other Medical Device Regulations World-Wide 0
dgrainger Informational MHRA Medical Devices Regulation Webinar - 24 January 2023, 10:00-11:30 GMT UK Medical Device Regulations 0
S EU Medical Device Regulations EU Medical Device Regulations 6
K Sample size calculation for the medical device with multiple indications. e.g. suture US Food and Drug Administration (FDA) 3
S Registation different version of Medical Devices & Germany competend authority EU Medical Device Regulations 3
Doninina Trend Reporting for medical device class IIb according to MDR EU Medical Device Regulations 4
C Medical Device Gamma Irradiation Validation per VDmax25 (ISO 11137) Qualification and Validation (including 21 CFR Part 11) 1
S Medical device other market Medical Device and FDA Regulations and Standards News 1
drwallice Registration of medical devices EU Medical Device Regulations 2
C Medical Simulators CE Marking (Conformité Européene) / CB Scheme 5
MaHoDie Is it possible to assign medical software to security class A (according to IEC 62304)? EU Medical Device Regulations 8
Stoic Warning letter examples for medical device companies related to the pharma guidance on data integrity? US Medical Device Regulations 5
A 510(k) and DeNovo on same medical device for different indications? US Medical Device Regulations 5
I ISO13485 Folder Structuring for Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 5
S Change in material vendor - Medical device ISO 13485:2016 - Medical Device Quality Management Systems 4
dgrainger Informational Published - Common specifications for the groups of products without an intended medical purpose listed in Annex XVI EU Medical Device Regulations 1

Similar threads

Top Bottom