Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178 ...

The MDR regulation is a mechanism for FDA and manufacturers to identify and monitor significant adverse events involving medical devices. The goals of the ... Medical Device Reporting · Device Labeling · Quality System (QS)

The EU revised the laws governing medical devices and in vitro diagnostics to align with the developments of the sector over the last 20 years.

Table of Contents · 1 - Interpretation · 2 - Application · 6 - Classification of Medical Devices · 8 - PART 1 - General · 68.01 - PART 1.1 - Medical Devices for ... Application · Interpretation · Issuance · Classification Rules

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178 ...

March 2020: The Commission announced on 25 March 2020 a proposal to postpone the application date of the Medical Devices Regulation (MDR) for one year. Manufacturers · Importers · Distributors · Contact

These Regulations contain the legislative measures necessary for the implementation of three European Community Directives: Council Directive 90/385/EEC on ...

TÜV SÜD can support manufacturers seeking to certify their medical devices for compliance with the European Union's Medical Device Regulation (MDR).

FDA regulates the sale of medical device products in the U.S. and monitors the safety of all regulated medical products. Medical Device Recalls · Medical Device Development · Device Safety · Databases

The Medical Devices Regulation (MDR) outlines requirements for medical devices. The MDR applies directly to all EU member states. National S.I.s (such as S.I.