European Regulations defining the terms Repair and Refurbish

E

eyalhend

#1
#1
Hello all,
I'm part of a company designing and manufacturing class II active devices.
I'm trying to figure whether the European regulations define the terms Repair and Refurbish, and provide requirements/guidelines on these two processes.
I assume that it is not suppose to be limited to labeling and ATPs.

Thanks!
 
Standard Work Instruction Software by Dozuki
Elsmar Forum Sponsor
P

Pads38

Moderator
#2
#2
Under the current directives (MDD 93/42) I do not think there is any reference to either repair or refurbishment.

Under the forthcoming Regulations (MDR) I think there are controls put in place to cover "re-manufacture". This demands that an operator that undertakes re-manufacture takes on the legal requirements of the device manufacturer.

(IIRC there are definitions as to what is repair versus re-manufacture).
 
shimonv

shimonv

Trusted Information Resource
#4
#4
I'm of the same option as Pads38 that the european community has not issued specific regulations regarding the use of repaired or refurbished medical device.

Cheers,
Shimon
 
E

eyalhend

#5
#5
Thanks all,
Regarding refurbishment, I could only locate reference in the guidance document from the European Coordination of Notified Bodies ‘Placing on the market of fully refurbished medical devices’ NB-MED/2.1/Rec5.
But the above refers to ‘Fully refurbished’ which is considered to mean that a
device has been completely rebuilt / made as new from used devices and is assigned a new ‘useful life’.
No reference to "partial" refurbishment. Thus, do you recommend not to including a protocol for such process but to include it under service activities?

Additionally, can someone send a strict definition for repair and refurbishment?

Thanks a lot!
Eyal
 
shimonv

shimonv

Trusted Information Resource
#6
#6
eyalhend said:
Additionally, can someone send a strict definition for repair and refurbishment?

Eyal
Click to expand...
Eyal,
The whole regulation for repair and refurbishment is still a work in progress.
Below is a set of purposed definitions taken from US Federal Register Number: 2016-04700.

1. Recondition: Restores and/or refurbishes a medical device to the OEM's original specifications. Under limited circumstances the medical device may be restored and/or refurbished to current specifications.

2. Service: Maintenance or repair of a finished device after distribution for purposes of returning it to the safety and performance specifications established by the OEM and to meet its original intended use. Servicing cannot change the intended use(s) of the device from its original purpose(s).

3. Repair: Return the device or component to original specifications including replacing non-working components or parts outside of routine or periodic upkeep for the current owner of the device.

4. Refurbish: Restore device to a condition of safety and effectiveness that is comparable to when new. This includes reconditioning, repair, installation of certain software/hardware updates that do not change the intended use of the original device, and replacement of worn parts.

5. Remanufacture: Process, condition, renovate, repackage, restore, or any other act done to a finished device that significantly changes the finished device's performance, safety specifications, or intended use.

6. Remarket: The act of facilitating the transfer of a previously owned device from one party to another by sale, donation, gift, or lease.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
M Informational TGA – European implementation of Medical Device and IVD Regulations – Implications for Australia Medical Device and FDA Regulations and Standards News 0
rob73 New MDD (European Medical Device Regulations) next steps - 2016 EU Medical Device Regulations 1
M Overview of European Regulations of Medical Device Other ISO and International Standards and European Regulations 12
N Confusion within CE Mark and European Regulations CE Marking (Conformité Européene) / CB Scheme 5
E External Training - EMEA (European Medicines Agency) Regulations Training - Internal, External, Online and Distance Learning 1
B IVD Veterinary Testing - European Market Regulations Other ISO and International Standards and European Regulations 6
P Best european location to set up for a virtual medical device manufacturer? EU Medical Device Regulations 4
A European UDI-DI CE Marking (Conformité Européene) / CB Scheme 2
F How to register class I device to all European Competent Autorities(CA) when we are European manufacturer EU Medical Device Regulations 4
dgrainger Medical Device News MDR postponed - link to Official Journal of the European Union (24-4-2020) EU Medical Device Regulations 2
P European versions of standards - ISO 10993-1 and ISO 11607-1 EU Medical Device Regulations 6
shimonv Recall - Is there a European regulation for recalls of products EU Medical Device Regulations 3
atitheya Need of conducting medical trials in European Union EU Medical Device Regulations 2
P ISO 10993-1:2018 - When will the European equivalent become a Harmonized Standard? Other Medical Device Related Standards 13
M Informational EU – Guidance document Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 of the European Parliament and of the Council o Medical Device and FDA Regulations and Standards News 2
M Informational European Commission expert panels on medical devices and in vitro diagnostic devices Medical Device and FDA Regulations and Standards News 0
Marc European universities dismal at reporting results of clinical trials - 2019 Other Medical Device Regulations World-Wide 0
M Informational Medtech Europe – Open letter to the European Commission on the implementation and readiness status of the new Medical Device Regulation (MDR) Medical Device and FDA Regulations and Standards News 0
M Informational Technology and innovation of human implants | Panel for the Future of Science and Technology (STOA) | European Parliament Medical Device and FDA Regulations and Standards News 0
M Informational EU – Draft Functional specifications for the European Database on Medical Devices (Eudamed) – First release (High(1)) to be audited Medical Device and FDA Regulations and Standards News 0
moounir Medical Device Nomenclature - Free of Charge? (European Union MDR MDR 2017/745) EU Medical Device Regulations 7
M Informational EU – Questions And Answers Related To The United Kingdom’s Withdrawal From The European Union With Regard To Industrial Products Medical Device and FDA Regulations and Standards News 0
N European Authorised Representative (also called Authorized Representative) - Cost competitive recommendation EU Medical Device Regulations 1
Marc Regulation (EU) 2017/745 of the European Parliament EU Medical Device Regulations 12
J Medical Device Registration in Argentina - Client asks us to provide “European FSC” Other Medical Device Regulations World-Wide 4
S CE ETA (A2) Audit - CE mark for the european construction market CE Marking (Conformité Européene) / CB Scheme 0
N Will an FDA UDI be compatible with a European MDR UDI? EU Medical Device Regulations 7
M Medical Device News MedTech Europe - European Parliament further clarifies Commission proposal on HTA for medical technologies EU Medical Device Regulations 0
W Sale medical device to European Hospitals Hospitals, Clinics & other Health Care Providers 1
R Brexit - European Commission - The impact of the Brexit per March 29, 2019 EU Medical Device Regulations 3
E European Weld Callouts - Confused with the "/C" and the "a2" portions Various Other Specifications, Standards, and related Requirements 7
H European Pharmacopoeia First Identification Requirements Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
Q IVD vs EMC OJ (Official Journal of the European Union) Harmonised Standard Conflicts EU Medical Device Regulations 1
S Medical Device Registration & Technical Format/Template - European Union CE Marking (Conformité Européene) / CB Scheme 8
L ISO 13485 and European GMP ISO 13485:2016 - Medical Device Quality Management Systems 3
Marc Definition PEPPOL - Pan-European Public Procurement Online Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 0
J Label translation requirements for EU (European Union) EU Medical Device Regulations 3
U What if UK leaves EU? What will happen to European Authorized representative in UK? EU Medical Device Regulations 22
E I'm looking for old publications of European Quality in pdf Book, Video, Blog and Web Site Reviews and Recommendations 2
F What is the European UDI implementation timeline? EU Medical Device Regulations 3
K May 16 2014 Official Journal of the European Union Publication - 60601-2-33 EU Medical Device Regulations 3
Ajit Basrur Is there an European equivalent of FDA Debarment List? EU Medical Device Regulations 2
P Is the European directive, 2011/65/EU applicable for Engineering Samples? RoHS, REACH, ELV, IMDS and Restricted Substances 5
Stijloor The European Union Explained Coffee Break and Water Cooler Discussions 4
E Current MRI Labeling requirement for European Union CE Marking (Conformité Européene) / CB Scheme 2
J0anne US Working Permit Requirements for European Consultants Career and Occupation Discussions 2
J European Laboratories which can do IEC/EN 60601-2-50 Testing? (Close to Turkey) IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
J EC Certificate and European Market Introduction CE Marking (Conformité Européene) / CB Scheme 8
W East European NB for MD - How are they when compared with Western NB's? EU Medical Device Regulations 6
D Auditing Abroad - Internal Audits of our European Sister Companies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16

Similar threads

Top Bottom