What directives/regulations apply to Analyte Specific Reagents (ASRs) in EU

F

fondantcookie

#1
Hi all. Apologies if this has been asked before but I've looked around an have not yet found the advise i'm seeking.

I was just wondering if anyone know what directives/regulations apply to ASRs in Europe and how these products should be labelled?

I realise ASRs are a US/FDA term and there is no equivalent in the EU as such, but we are wanting to start selling these products in the EU...

Huge thank you in advance.
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
M Informational EU – Manufacturer incident report (MIR) for serious incident- template 2020 (Directives and new regulations) version 7.2 and related documents Medical Device and FDA Regulations and Standards News 2
M Medical Device News EU – Transition Timelines from the Directives to the Regulations – Medical Devices and in vitro Diagnostic Medical Devices Medical Device and FDA Regulations and Standards News 13
W Directives and regulations required for medical implants with RFID sensors ISO 13485:2016 - Medical Device Quality Management Systems 9
dgrainger Informational EU published new Harmonised Standards List for the Directives (25/3/2020) Medical Device and FDA Regulations and Standards News 0
M Informational EU – Application of transitional provisions concerning validity of certificates issued in accordance to Directives 90/385/EEC and 93/42/EEC Medical Device and FDA Regulations and Standards News 2
B How to assess which directives and standards apply - Brewing and distilling products CE Marking (Conformité Européene) / CB Scheme 1
M Medical Device News Medical Device Directives – New templates for Field Safety Notices published Medical Device and FDA Regulations and Standards News 0
M Electrical and Electromechanical Product CE Compliance with various Directives CE Marking (Conformité Européene) / CB Scheme 22
W How to show compliance to multiple CE Directives ? CE Marking (Conformité Européene) / CB Scheme 4
M ISO 14971, IEC 60601 Satisfy 98/37/EC, 2006/95/EC, 2004/108/EC Directives? Other ISO and International Standards and European Regulations 3
D Suitable CE Mark Directives - Product Families CE Marking (Conformité Européene) / CB Scheme 3
somashekar Are the 93/42/EEC and the 2011/65/EU directives mutually exclusive directives? EU Medical Device Regulations 1
O Directives 1935/2004/ЕС and 2023/2006 and Enameled Metalware CE Marking (Conformité Européene) / CB Scheme 1
M Proposal for revision of the Medical Devices Directives in Europe EU Medical Device Regulations 10
M CE Mark for MD and RTTE Directives with different NBs EU Medical Device Regulations 4
F FAA Repair Shop Airworthiness Directives (AD) Application Help Federal Aviation Administration (FAA) Standards and Requirements 2
N CE Mark (CE directives) for Welding Electrodes CE Marking (Conformité Européene) / CB Scheme 5
C I'm going crazy with Pharmacopeia & EU Directives CE Marking (Conformité Européene) / CB Scheme 2
T Technical Directives (TD's) not used for Technical Updates - Audit Nonconformance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
S Directives for Classifying Standalone Software as Medical Devices CE Marking (Conformité Européene) / CB Scheme 3
P Do MDD (Medical Device Directives) Devices require MDD components? EU Medical Device Regulations 17
xcanals_tecno-med.es Revised List of Harmonized Standards for Medical Device Directives (MDD) in the EU EU Medical Device Regulations 48
T Bluetooth Class II Medical Device - Which Directives? EU Medical Device Regulations 5
I Do Research Laboratory Instruments fall under the MDD and IVD Directives EU Medical Device Regulations 3
xcanals_tecno-med.es Revised list of harmonized standards for medical device directives in the EU (7/7/10) EU Medical Device Regulations 0
W CE Directives for a Passive "Filter/Duplexing" Telecom Device CE Marking (Conformité Européene) / CB Scheme 2
J Which directives? CE marking for some of our in-house products EU Medical Device Regulations 9
M Revised list of harmonized standards for medical device directives in the EU EU Medical Device Regulations 1
Ajit Basrur Amendments in RoHS and WEEE Directives (3rd Dec 08) RoHS, REACH, ELV, IMDS and Restricted Substances 1
T Classification of Bio-diagnostic Products as per EU Directives ISO 13485:2016 - Medical Device Quality Management Systems 3
S Mention European Directives 97/23/EC, 99/36/EC and 93/42/EC in one of our Procedures? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Manix Why are pages left blank on Specifications, Standards, and Directives etc? Document Control Systems, Procedures, Forms and Templates 5
J MD Compliance for Dummies - Relation between devices, directives and standards ISO 13485:2016 - Medical Device Quality Management Systems 3
C European Union Environmental Product Directives ELV, WEEE/ RoHS RoHS, REACH, ELV, IMDS and Restricted Substances 26
A ISO 9001 vs. CE Mark European directives CE Marking (Conformité Européene) / CB Scheme 3
L Single-cell lithium ion battery regulations IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
L Saudi regulations for Japanese non sterile scopes Japan Medical Device Regulations 0
L ANVISA’s RDC 665 replaces previous regulations including RDC 16/2013 and IN 08/2013, and comes into effect on May 2, 2022 Other Medical Device Regulations World-Wide 0
M Seeking mentor/consultant for orthopaedic soft goods regulations Job Openings, Consulting and Employment Opportunities 0
D Regulations covering Sterile product shipments ISO 13485:2016 - Medical Device Quality Management Systems 1
R Medical device regulations in African countries Other Medical Device Regulations World-Wide 0
R Regulations on Controlled Document Size (Paper Size) Document Control Systems, Procedures, Forms and Templates 4
Z Swiss Authorized representative & non-medical device regulations Other Medical Device Regulations World-Wide 0
N How to validate Regulations and Standards? ISO 13485:2016 - Medical Device Quality Management Systems 12
G How to record Regulations and Standards as Design Inputs? Design and Development of Products and Processes 15
L EOL milestone in Medical Devices Regulations 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
dgrainger Informational DRAFT: The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 UK Medical Device Regulations 1
dgrainger Informational DRAFT: The Medical Devices (Northern Ireland Protocol) Regulations 2021 UK Medical Device Regulations 1
B Regulatory Affairs Certification (RAC) Book - Fundamentals of Medical Device Regulations Medical Device and FDA Regulations and Standards News 0
J In-house (NHS) manufacture and use (by staff) of non-medical devices.. any regulations apply? UK Medical Device Regulations 6

Similar threads

Top Bottom