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Medical devices

Key guidance and resources in the area of medical devices

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IVD

Key guidance and resources in the area of medical devices


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Trade Compliance

Key guidance and resources in the area of medical devcies

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Other regulations

GDPR, NRC, USDot and other regulations effecting medical devices

MDR Links

Below you find the key documents that everyone needs to look into

MDR Guidance Information
All MDCG GuidanceHere you find all Guidance document issues by MDCG
ClassificationStart point for all medical devices
Software classificationIf you have a software product you also need to read this one
Clinical evaluationAll devices need a clinical evaluation
MDRThe regulation itself
Significant changesWhat is a significant change which might trip over your MDD product to MDR
MDCG GuidanceEU Guidance to the regulation
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IVDR Links

Below you find the key documents that everyone needs to look into

MDR Guidance Information
All MDCG GuidanceHere you find all Guidance document issues by MDCG
ClassificationStart point for all IVD devices
Software classificationIf you have a software product you also need to read this one
Clinical evaluationAll devices need clinical performance evaluation
IVDRThe regulation itself
MDC GuidanceEU Guidance to the regulation
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Trade compliance links

Below you find the key documents that everyone needs to look into. Trade compliance effects all companies

EU Export control  Information
Export from EUWhat applies when you export from EU to other countries
Overview export controlEU overview page of applicable requirements to consider
The EU export control regulationThe main export control rules, classification etc
EU Sanction listThis is the list for EU sanctions towards countries, persons etc
EU National requirementsNational deviations and additional requirements
Research guidanceWhat applies for research projects from a export control view
EU Chemical export requirementsSpecific guide about exporting chemicals for e.g. IVDs
International organizationsInformation
Nuclear suppliers groupInternational group about radiating material export control requirements
Wassenaar groupThe Wassenaar group discussing export control internationally
The Australia groupThe Australia group discussing export control internationally
USA Export controlInformation
BISBIS. All export control activities except embargo countries
The regulationThe regulation with all lists needed
OFACOffice of Foreign Assets Control handles embargo countries
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Other Links to EU regulations

Below assorted requirements that applies to medical devices, IVDs or laboratory equipment

GDPR Information
GDPRHere you find the GDPR regulation in EU
MDThe machine directive, applicable to products with moving parts
LVDLow voltage directive applies for products between 50 V AC/75V DC up to 1000/1500V 
EMCEMC requirements
Blue bookThe basis for all regulations/Directives in EU. Describes the framework!
765/2008Regulation on market surveillance, compliance of products  and required responsible person
REACHRegulations for chemicals applies to all products non CE marking
RohsRestrictions for certain substances
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Contacts

Email: info@lowendahl.eu
Phone: +46 (0) 722 31 33 55

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