Medical Device Risk Assessment Under ISO 14971:2019
At the time of this article, it has been approximately four years since the publication of ISO 14971:2019. However, while…
Resources & News
Stay informed with real-time regulatory news and expert insights, and keep the conversation going by connecting with us on social media.
Showing 37–45 of 59
MDR EU Regulation Requirements: Systems and Procedure Packs
Under Article 2 of the MDR, a “system” is a combination of products, either packaged together or not, which are…
EU Device Regulatory Compliance: A Comprehensive Guide
While the focus of EU regulatory compliance for medical devices and…
MDR Clinical Evaluation Reports for Lower-Risk Class Devices
It is known that the main objective of the implementation of the MDR was to strengthen the regulatory framework…
Technical Documentation Files Review: Top 5+ Mistakes by Manufacturers
As a regulatory representative for foreign manufacturers in the EU, UK, US and Switzerland, MedEnvoy reviews technical documentation files of…
MDR Transition Extension Period: Understanding the New Regulation 2023/607 for Device and IVD Manufacturers
On January 6, the EU Commission finally took steps towards addressing…
EU MDR
Swiss Importer
EU IVDR
EU Importer
General
UK Responsible Person
UK Importer
Swiss Authorized Representative
Consolidating Authorized Representative and Importer Roles Pros and Cons
In this article, we share the advantages and disadvantages associated with consolidating the roles of authorized representative and importer.
New Product Liability Directive Proposal | Medical Devices/IVDs
More than 30 years since the Product Liability Directive (PLD) was established and after the Commission assessed its regulatory…
Why You Need To Get MDR Certification In 2023
If your plan was to wait until 2023 to leisurely address compliance with the Medical Device Regulation (MDR 2017/745) and…
Showing 37–45 of 59