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Renewal Timelines Quickly Approaching for Medical Device Directive (MDD:M5) CE Mark Certificates

The countdown for the EU Medical Device Regulation (MDR 2017/745 EU), what will soon be the only governing EU medical device regulation, is quickly approaching. The compliance deadline of May 2020 may seem quite far away, but with a significant reduction in Notified Body capacity, a sizable increase in demand for regulatory certification services is … Continued

Effective Implementation of EN ISO 14971 Medical Device Risk Management Standard

Risk management is an important lifecycle product development requirement for all medical device organizations when developing, manufacturing, and commercially distributing medical products. To appropriately address issues of potential risk within the European Economic Area (EEA), manufacturers must utilize the harmonized standard, EN ISO 14971:2012, to meet regulatory requirements. However, EU device manufacturers often struggle to … Continued

CE Marking of Digital Health Technologies: Stricter Rules for Medical Device Software under the EU MDR

Introduction Increasingly, the world is engaged in conversations surrounding mobile and digital health applications. These types of platforms – broadly defined – encompass everything from pedometers, fitness apps, exercise diaries and even products that monitor health conditions such as diabetes, heart disease and depression. European manufacturers of such digital health technologies, medical applications and wearable … Continued

The Importance of Human Factors & Usability Engineering in Medical Devices

Human factors principles have long been applied in high-hazard industries such as aerospace, nuclear, petrochemical, energy and transport in an effort to minimize potential risks. Increasingly, human factors in the life science industry have become recognized as an important topic. While human factors engineering was previously only accepted as necessary for electro-medical devices with complex … Continued

UK MHRA Publishes Guide to the New EU Medical Device and IVD Regulations

On August 29, 2017, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) published an interactive guide to assist Medical Device and In Vitro Diagnostics (IVD) companies with a comprehensive understanding of the new and different EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) requirements. The MDR and IVDR … Continued

EU MDR Poses Significant Changes for Importers and Distributors

The European Union’s (EU) Medical Device Regulation (MDR), officially passed in April of 2017, may cause significant changes to the regulatory obligations of legal manufacturers, importers and distributors involved in the medical device distribution chain. The new MDR regulations differ significantly from the current EU Medical Device Directive (MDD) and go beyond design, development and … Continued

Risk: An Emerging Driver for New Regulatory Requirements

Risk management is a relatively young management concept. During the last ten to 15 years, it has evolved from a technical economic discipline with roots in insurance, finance and engineering into a central theorem that has permeated regulatory and management domains. Increasingly, it is becoming one of the main topics of conversation, and marketplace catalyst, … Continued