Eudract And Medical Devices

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EudraCT Public website - Home page

https://eudract.ema.europa.eu/

EudraCT (European Union Drug Regulating Authorities Clinical Trials Database) is the database for all interventional clinical trials on medicinal products submitted to the National Competent Authorities (NCAs) of the European Union …

EudraCT & EU CTR Frequently asked questions

https://eudract.ema.europa.eu/docs/guidance/EudraCT%20FAQ_for%20publication.pdf

The EudraCT database covers only interventional clinical trials using investigational medicinal products (IMP) conducted in the EU/EEA and outside the EU/EEA if they are …

EudraCT & EU-CTR Question and Answer table

https://eudract.ema.europa.eu/help/content/resources/documents/EudraCT%20FAQ_for%20publication.pdf

EudraCT database covers only interventional clinical trials using investigational medicinal products (IMP) co nducted in the EU/EEA and outside the EU/EEA if they …

Eudamed and CTIS: Lessons from EudraCT - Health …

https://haiweb.org/publication/eudamed-and-ctis-lessons-from-eudract/

Two European databases currently being developed and due to go live at the start of 2022, the Clinical Trials Information System (CTIS) and the European Databank on Medical …

New guidance and information for industry from the MHRA

https://www.gov.uk/government/collections/new-guidance-and-information-for-industry-from-the-mhra

The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK’s standalone medicines and medical devices regulator. The below guidance should …

EUDRAC | Medical Devices

https://www.eudrac.com/services/medical-devices

CE Mark (Conformité Européenne - European Conformity) Devices that are intended to be used for medical purposes are required to be CE marked under MDR (EU) 2017/745 …

New | EudraCT: Clinical trials in EU need to …

https://www.asphalion.com/news/eudract-clinical-trials-conduted-in-the-eu-need-to-be-registered-with-the-eudract/

In June 2019, the EC, the EMA and the HMA co-signed a letter reminding all sponsors of clinical trials conducted in the EU of their obligation to make …

EudraCT Public website -NCAs page - Europa

https://eudract.ema.europa.eu/nca_contacts.html

[email protected]

EudraGMDP database | European Medicines Agency

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

This content applies to human and veterinary medicines. The EudraGMDP database is the Community database on manufacturing, import and wholesale-distribution …

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 …

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