Tag: MDR

Consulting

The Role Of Notified Bodies Under The EU Medical Devices Regulation

The EU Medical Devices Regulation (MDR) was published on May 5, 2017. The impetus behind these new, more rigorous regulations was in part to reflect the substantial technological and scientific advances made by the medical device sector and in part a response to the need for regulations that would significantly tighten the controls around medical...

Global Compliance

Strategic Planning for Compliance With the EU Medical Device Regulation

Compliance with the EU Medical Devices Regulation (MDR) is a significant undertaking that requires cross-functional collaboration. In this post, we explore key activities involved in strategic planning for compliance. Establishing a leadership team Good leadership is essential for managing the transition to EU MDR compliance and creating an execution strategy which includes timelines and mechanisms...

Consulting

FAQ: How the EU Medical Devices Regulation Affects Existing Products

With the looming deadline for compliance with the EU Medical Devices Regulation (MDR), device manufacturers face a host of questions about how to prepare their existing products for compliance. In this post, we provide answers to top questions about EU MDR compliance. Is it possible to avoid compliance with the EU MDR? The short answer...

Medical and Regulatory Affairs

Premier Voices #5: Operationalizing the New MDR With Janet Kube (Part 1)

If you sell medical devices in Europe and haven’t made plans to comply with the EU’s new Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR), it’s time to step things up. The new MDR and IVDR rules adopted a little over a year ago do have generous phase-in periods — three years for...

Medical and Regulatory Affairs

7 Questions About Clinical Evaluations for MDR

After years in development, the final version of the Medical Device/In Vitro Diagnostic Medical Device Regulations was published in the Official Journal of the European Union on May 5, 2017. These regulations superseded the previous Directives for the European market and will be implemented over the next few years. In our last post, we went over...

Consulting

Europe’s Medical Device Regulation: Get to Know the Basics

The regulatory landscape for medical devices in Europe is undergoing some major changes. Published in May 2017, the new European Medical Device Regulation (MDR) (Regulation [EU] 2017/745) and In Vitro Diagnostics Regulation (IVDR) (Regulation [EU] 2017/746) is gradually replacing the Medical Devices Directive and the Implantable Medical Devices Directive in the European market. Although the...