Regulations in Medical Devices – Thematic Research

The next few years will be challenging for medical device companies as regulatory requirements undergo overhauls in Europe, Canada, and the US. The ability to navigate this new legislation is the key to success, especially as the new Medical Device Regulation (MDR) in Europe will require significantly longer clinical research and certification processes before products can be approved. As old regulations are discarded and devices are assessed according to the new standards, even perfectly compliant medical devices could face significant barriers in maintaining or gaining market approval.


This is a single theme report providing in-house analyst expertise on medical device regulations.

Components of the report include:

Key Players — identify the key medical device regulatory agencies by country.

Trends — identify the key trends impacting medical regulations over the next 12 to 24 months.

Industry Analysis — identify the impact of regulations on the approval of devices.

COVID-19 Impact – Identify the impact of COVID-19 on medical device regulations.

Key Highlights

This report looks at the state of the medical devices regulation landscape. Over the next five years, there will be strong growth in Europe and the US, which together make up the majority share of the global medical devices market. The US and Europe also have immense influence in how medical technology is developed and brought to market.

Reasons to buy

Develop and design your corporate strategies through an in-house expert analysis of medical device regulations by understanding the primary ways in which regulations are changing.

Identify emerging trends in medical device regulations to gain a competitive advantage.

Understand the impact of COVID-19 on medical device regulations.

Table of Contents

Executive Summary


Thematic Briefing


Industry Analysis

Impact of COVID-19 on Cybersecurity in Medical


Our Thematic Research Methodology


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