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 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and …

2024年7月10日 · Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establish that Notified… Latest updates News announcement

They are regulated at EU Member State level, but the European Medicines Agency (EMA) is involved in the regulatory process. Manufacturers can place a CE (Conformité Européenne) mark on a medical device once it has passed a conformity assessment.

Are you looking for the latest consolidated text of the EU MDR? Click here. Listed below are some of the most recent publications supporting the implementation of the EU MDR. Update of MDCG 2019-6 rev.5 - Questions and answers: Requirements relating to notified bodies.

Commercializing medical devices in the European Union (EU) requires a CE marking demonstrating compliance with the medical device regulations. The CE marking indicates that the legal manufacturer has assessed the device and that it meets the General Safety and Performance Requirements under the MDR 2017/745.

Do you know the requirements and your responsibilities for medical device vigilance reporting? What are the requirements for vigilance reporting and post-market surveillance? What does the future look like for the medical devices industry?

2023年4月14日 · Get your CE marking under the new requirements of EU MDR for the commercialization of your medical device in the European marketplace in 5 steps.

2022年2月8日 · What Is a CE Mark? A CE mark is a physical mark that goes on your product. It indicates that your medical device complies with the standards outlined by the EU MDR. These regulations are in place to certify that your medical device is safe for users, performs as intended, and is a quality product.

Find out how to compile an MDR technical file, obtain CE Marking and start selling your medical devices in Europe.

2023年10月12日 · Medical devices manufacturers willing to market products in the European Union (EU), must comply with the regulations established by the European Union Medical Device Regulation (MDR). One of the essential requirements for selling medical devices in the EU is obtaining the CE marking.