Ema Medical Device Guidance

At Manningham Medical Centre, you can find all the data about Ema Medical Device Guidance. We have collected data about general practitioners, medical and surgical specialists, dental, pharmacy and more. Please see the links below for the information you need.

Medical devices | European Medicines Agency

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

The medical device may be co-packaged with, obtained separately from or integral to the medicinal product. EMA issued a final guideline on quality documentation for medicinal products that include a medical device in July 2021. This clarifies …

Quality documentation for medicinal products when used …

https://www.ema.europa.eu/en/quality-documentation-medicinal-products-when-used-medical-device-scientific-guideline

This guideline describes the information that should be presented in the quality part of a marketing authorisation dossier for a medicinal product when it is …

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. The …

QWP-BWP Guideline on medicinal products used …

https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-quality-documentation-medicinal-products-when-used-medical-device-first-version_en.pdf

The guideline is also applicable to the following configurations where a medicinal product and a medical device are not placed on the market as a single integral unit, but the …

Guideline on the quality requirements for drug …

https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-quality-requirements-drug-device-combinations-first-version_en.pdf

Devices intended to administer a medicinal product, where they form a single integral product 68 intended exclusively for use in the given combination and which is not …

Guidance - MDCG endorsed documents and other guidance

https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en

The majority of documents on this page are endorsed by the Medical Device Coordination Group (MDCG) in accordance with Article 105 of the MDR and Article 99 of the IVDR. …

Scientific advice and protocol assistance | European …

https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-advice-protocol-assistance

The European Medicines Agency (EMA) can provide medicine developers advice on the most appropriate way to generate robust evidence on a medicine's benefits and risks. …

Product information: Reference documents and guidelines

https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/product-information/product-information-reference-documents-guidelines

This page lists the reference documents and guidelines on the quality of product information for centrally authorised human medicines, including style, terminology, use …

Guidance Documents (Medical Devices and Radiation …

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products

Guidance documents are documents prepared for FDA staff, regulated industry, and the public that describe the agency's interpretation of or policy on a regulatory issue. …

Need more information about Ema Medical Device Guidance?

At Manningham Medical Centre, we collected data on more than just Ema Medical Device Guidance. There is a lot of other useful information. Visit the related pages or our most popular pages. Also check out our Doctors page.