European requirements for rechargeable Lithium-ion batteries going to be used in Electronic Pipette

Harsh

Involved In Discussions
#1
Hello Everyone,

I was wondering about the European compliance requirements for rechargeable Lithium-ion Batteries, which will be used in our Electronic Pipettes. Do batteries fall under CE marking requirements?

If yes then please suggest the appropriate directive with the harmonized standard for testing. And if not, what are the essential requirements we need to fulfill as a Non-EU manufacturer? Please share the requirements with the appropriate standard for the same.

Also which symbols should be available on the battery itself according to the European requirements? Please note that we do not manufacture batteries & just outsource them. So kindly suggest that as a buyer which requirements should be assured as a Non-EU manufacturer from our battery supplier so that we can provide the batteries separately to our European customers in case of warranty claims or as a spare.

Thanks in advance.
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
P Requirements for being an European Representative EU Medical Device Regulations 3
H European Pharmacopoeia First Identification Requirements Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
J Label translation requirements for EU (European Union) EU Medical Device Regulations 3
J0anne US Working Permit Requirements for European Consultants Career and Occupation Discussions 2
Q Quality System Requirements for a European Company w/ US Subsidiary ISO 13485:2016 - Medical Device Quality Management Systems 11
S European (CE) Device Label Requirements - Visibility EU Medical Device Regulations 2
N European Medical Device Labeling Requirements - Electrical Muscle Stimulator EU Medical Device Regulations 11
I European Authorized Representative - Their Requirements (Class 1 Medical Devices) EU Medical Device Regulations 6
Q European Translation Requirements - English to German - Medical Device User Manuals EU Medical Device Regulations 9
S AS9100 and EN9100 listed on Certificate - European business certificate requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
O CE Mark requirements for Class IIA MDs - European medical devices importers EU Medical Device Regulations 6
gard2372 A2LA & ISO/IEC 17025:1999 vs. European Requirements ISO 17025 related Discussions 7
sonflowerinwales European Council Requirements for Small Businesses Coffee Break and Water Cooler Discussions 2
A ISO/TS 16949 European Customer Specific Requirements Customer and Company Specific Requirements 4
H Audit Checklist for European Authorized Representative EU Medical Device Regulations 0
H Regarding confusion of the validity of the European implementation of IEC standards Other Medical Device Related Standards 1
C European Technical File for registration in Australia CE Marking (Conformité Européene) / CB Scheme 5
P European Medical Device Nomenclature (EMDN) and CND EU Medical Device Regulations 13
B European Harmonized vs IEC standard IEC 62366 - Medical Device Usability Engineering 2
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 4
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 TGA – European implementation of Medical Device and IVD Regulations – Implications for Australia Medical Device and FDA Regulations and Standards News 0
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 13
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
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
E European Regulations defining the terms Repair and Refurbish EU Medical Device Regulations 5
Marc Definition PEPPOL - Pan-European Public Procurement Online Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 0

Similar threads

Top Bottom