Co-Founder and CEO of Greenlight Guru, the only quality management software platform designed specifically for medical device companies.
As I discussed in a previous article about how to bring a medical device to market in the United States, Gartner projects nearly $8 billion in spending on sports watches and wristbands by 2021.
This lucrative marketplace, combined with a global pandemic, has driven many consumer-based tech companies to dive headfirst into the medical device market. Tesla has retooled vehicle parts to create ventilators, while others, like Apple and Casetify, have donated millions of masks and products like sanitizer to help protect frontline workers.
The focus on creating change is a global effort. With a population of 447 million, the European Union is second only to the United States in terms of market buying power. Historically, it was assumed that the path to market in Europe was easier than that of the U.S. Despite this changing, it’s critical for medical device manufacturers, or would-be manufacturers, to have a presence in the European marketplace to remain competitive.
Similar to the United States, the EU has a defined set of regulations for medical devices that every company must follow. These requirements are outlined in the European Commission Regulation (EU) No. 2017/745, otherwise known as the Medical Device Regulation (MDR).
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Another process to note when launching a device in Europe is obtaining a CE marking. This certification mark indicates device conformity with the applicable medical device regulations and allows the product to gain market access in the EU.
Just like in the U.S., you will need to start by determining the classification of your medical device according to its risk profile. Your device classification will determine which specific regulations you must be in compliance with before product distribution into the EU marketplace.
There are four classes of medical device outlined in the MDR: Class l (low/medium risk), Class lla (medium risk), Class llb (medium/high risk) and Class lll (high risk).
Class I devices can be self-certified, so your technical file will not be subject to a third-party audit. The purpose of a technical file is to demonstrate that your device meets the applicable and current regulations.
For all other risk classes, you’ll need to consult with an independent organization called a “notified body.” Notified bodies are designated by an EU country to conduct conformity assessments that ensure regulatory requirements are met.
Stricter requirements found in the EU MDR, compared to its preceding directive, have made it seemingly more challenging for notified bodies to remain actively certified. Due to this resource shortage, you must plan ahead so you can identify a notified body that has the capacity to help you meet your project timeline.
Quality Management System
A quality management system (QMS) is a formalized system that houses every document and record, design specification, process and procedure related to a medical device. A quality system is not only critical for organizations to facilitate communication and ensure the production and maintenance of safe and effective medical devices, it is a regulatory requirement of EU MDR.
The International Organization for Standardization (ISO) published the globally harmonized standard for medical device quality management systems, known as ISO 13485:2016, which lays out all applicable guidelines. The most recent updates to EU MDR also mandate the use of a QMS.
Quality management systems used to consist of a quality manager and a filing cabinet. However, with the emergence of technology, these outdated systems have been replaced with cloud-based QMS software solutions designed to maintain various required processes, including:
1. Design controls and design history file
2. Document management
3. Risk management
4. Corrective and preventive action (CAPA)
5. Audit-ready procedures
Implementing and maintaining a QMS is one of the final steps in obtaining CE marking, in addition to assembling a technical file to comply with EU MDR. This artifact will be used by your notified body when conducting a conformity assessment audit to prove and ultimately declare the conformity of your medical device.
The goal of design controls is to accurately trace all elements of the design and development process for a medical device, ensuring safety and efficacy for the end-user.
Through the use of design controls, manufacturers are able to prove the safe and effective design and development of a device. It’s also important to note that design controls may require retroactive work, such as post-market events that require corrective action, in which the root cause must be identified to correct the issue.
Although time-consuming and tedious, this process is essential to the commercialization and market sustainability of a medical device.
ISO has also laid out guidelines for the management of risk, as it pertains to medical devices, in its publication of the risk management standard for medical devices ISO 14971:2019. The European Commission followed suit with updating requirements to include risk management guidelines in the EU MDR.
Simply having good design controls in place is not enough to eliminate potential sources of risk. Rather, risk management is an equally important process that should work in tandem with design controls and other key processes within a quality system.
An effective way to manage medical device risk is by leveraging a best-in-class QMS. Industry-specific solutions, purpose-built exclusively for medical devices, serve as the guardrails to ensure regulatory compliance, protect against potential problems that may occur and enable product and process improvement throughout the lifecycle of a medical device.
Bringing a medical device to market in Europe is no easy undertaking, even for the most experienced device manufacturer. However, by using best-of-breed tools and implementing a strategic quality and regulatory plan early on, you can reduce significant uncertainty and increase your chances for market success and sustainability.