Get Epar - Scientific Discussion - European Medicines Agency

The European Commission is the authorising body for all centrally authorised product, who takes a legally binding decision based on EMA's recommendation. This decision is issued within 67 days of receipt of EMA's recommendation.

The main difference between EU MDR and FDA for connected devices is the classification process itself. Most devices in the US get to market via the 510(k) pathway, so device classification is determined by finding a predicate device and matching the class.

An EPAR provides public information on a medicine, including how it was assessed by EMA. The EPAR is referred to in Article 13(3) of Regulation (EC) No 726/2004, which requires EMA to publish a public assessment report for each centrally authorised medicine together with a public-friendly overview.

A set of documents describing the evaluation of a medicine authorised via the centralised procedure and including the product information, published on the European Medicines Agency website. European public assessment reports include the product information. Abbreviated as EPAR.

European Medicines Agency (EMA) : EMA is a decentralized body of the European Union, located in Amsterdam in the Netherlands. It is responsible for the scientific evaluation, supervision, and safety monitoring of medicines for human and veterinary use in the EU.

The EMA is the European Union's equivalent to the U.S. Food and Drug Administration (FDA).

BfArM - Federal Institute for Drugs and Medical Devices.

The FDA is a centralized agency that oversees the drug development process in a single country, whereas the EMEA is a reviewing body that manages the process in many European nations.