Knowledge Hub

The UDI Requirements of the New EU MDR – What You Need to Know

by Fidelma Conway
The new EU MDR (Medical Device Regulation) changes several aspects of obtaining and then maintaining regulatory approval for medical devices. One of the major changes is the introduction of an identification system, or UDI, for medical devices approved for use in the EU. While the implementation of the new EU MDR has been delayed because of COVID-19, everyone in the industry is impacted by this change in UDI requirements. This includes those with products that have been on the market for years, to companies and start-ups developing new medical devices that have yet to go through the approval process. Introduction...

Using Coil Reinforced Polymer Tubes with Ultra-Thin Walls to Develop Advanced Catheter Technologies

by Ger O'Carroll
Coil reinforced polymer tubes have enabled the development of a wide range of minimally invasive medical devices, including catheter solutions. The coil reinforcement increases the flexibility of the device inside the body, preventing the tube from kinking or collapsing. These kink-resistant capabilities make it possible for catheters to access difficult to reach parts of the body. As a result, many coil reinforced catheter solutions have been developed and are currently being used for both diagnostic and therapeutic purposes. Just because there are effective coil reinforced catheter solutions in use doesn't mean the medical device industry can declare mission accomplished, with...

Getting Started with Your Idea for a Medical Device

by Mark Pugh
You have an idea for a new medical device. What do you do now? What are the next steps you should take? Each medical device development project is different, but there are common steps regarded as best practices in the industry. You might have already gone through some of the points below, but this will give an overview of the first stages of the medical device design and development process. Ideation As you already have an idea for a new medical device, you are likely to be part of the way through this stage. It’s helpful to review what ideation...

How Much Will It Cost to Commercialise Your Idea for a New Medical Device?

by Arrotek Medical Ltd
Do you have an idea for a new medical device and want to know how much it will cost to get it from where you are now to the point that it is regulatory approved and ready for commercialisation? Do you also want to know the steps involved and the timescale that is likely to apply? At Arrotek, we have extensive experience designing and developing new, innovative, and cutting-edge medical devices, particularly minimally invasive medical devices. Therefore, we are asked the above questions a lot. So, we decided to make getting the answers as easy as possible. Introducing Our Medical...

Managing Medical Device Design Project Risks

by Mark Pugh
In medical device design projects, there are both product risks and project risks. Product risks are talked about a lot as they are about the safety and effectiveness of the product. Managing product risks is also an essential part of the regulatory approval process. From a commercial perspective, project risks are critical too. Therefore, it’s also important to manage project risks when designing a new medical device. Product Risk Management vs Project Risk Management Product risk management is about product safety and ensuring the product does what it is expected to do. There are well-document guidelines, standards, and requirements you...

New European MDR – Key Steps to Take at a Time of Uncertainty

by Arrotek
Issues surrounding the implementation of the European Union’s new Medical Device Regulations (MDR) are a hot topic of conversation right now in the medical device industry. After all, that implementation starts in May of this year while today, significant challenges exist. Those challenges include the availability of MDR-designated Notified Bodies, the high workloads currently being experienced by those Notified Bodies, the uncertainty around grace periods, and the availability of EU-published guidance. These issues are now well-known and they are discussed and debated regularly. For example, they are scheduled to be key discussion points at the MedTech Live event taking place...

Medical Device Product Compliance – Key Questions to Ask

by Arrotek
There are key questions you need to ask about your new medical device idea as part of the process of getting approval from regulators in the markets you plan to launch in. Our animation outlines the key compliance questions you will need to answer. Watch now:  

An Introduction to Standard Operating Procedures

by Arrotek
When you design and develop a new medical device product, you must establish, manage, and enforce standard operating procedures, otherwise known as SOPs. What are SOPs, though, why do you need them, when do you need them, and what do you need to do? Before getting into those questions, let's look first at why SOPs are important even when you are at the early stages of developing your concept for a new medical device. Having SOPs in place and enforcing them is a requirement of regulators around the world, including in Europe and the US. More specifically, SOPs are part...