Ema Medical Device

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Medical devices | European Medicines Agency

https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices

EMA has distinct regulatory responsibilities per category of medical device, including in vitro diagnostics. They are as follows: Medicines used in combination with a medical device ─ EMA assesses the safety and effectiveness of medicines used in …

Medical Device Regulation comes into application

https://www.ema.europa.eu/en/news/medical-device-regulation-comes-application

Medical Device Regulation comes into application. Regulation (EU) 2017/745 on medical devices becomes applicable in the European Union today, 26 May 2021. …

Medical Devices - EUDAMED - Public Health

https://health.ec.europa.eu/medical-devices-eudamed_en

On 1 December 2020 the European Commission has made available the Actor registration module.It is the first of six EUDAMED modules.EUDAMED… UDI/Devices registration …

EUDAMED database - EUDAMED - European Commission

https://ec.europa.eu/tools/eudamed/

The creation of a European database on medical devices (EUDAMED) is one of the key aspects of the new rules on medical devices ( Regulation (EU) 2017/745) and in vitro …

EudraGMDP database | European Medicines Agency

https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice/eudragmdp-database

The EudraGMDP database is the Community database on manufacturing, import and wholesale-distribution authorisations, and good manufacturing-practice (GMP) and …

The European Union Medical Device Regulation – …

https://eumdr.com/

Publication of MDCG 2021-12 FAQ on the European Medical Device Nomenclature (EMDN) Publication of MDCG 2021-11 Guidance on Implant Card “Device types” Publication of a …

Mandibular Advancement Device - EMA® …

https://glidewelldental.com/solutions/sleep-dentistry/mandibular-advancement-devices/ema

The EMA (Elastic Mandibular Advancement) oral appliance is a customized removable appliance created for the noninvasive treatment of snoring and obstructive sleep …

EMA Guidance on Medicines Used in …

https://www.regdesk.co/ema-guidance-on-medicines-used-in-medical-devices/

The European Medicines Agency (EMA) has published guidelines on quality documentation for medicinal products when used with a medical device. …

Emergency Use Authorizations for Medical …

https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations-medical-devices

Since February 26, 2016, when the Secretary of Health and Human Services (HHS) declared that circumstances exist justifying the authorization of the emergency use of in …

EMA - DynaFlex

https://www.dynaflex.com/dental-sleep-laboratory-devices/ema-appliance/

The Elastic Mandibular Advancement (EMA) appliance is the smallest of our obstruction sleep apnea appliances. The individual trays are constructed of 2mm vacuum form …

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