Understanding Compliance Requirements Under the EU Medical Device Regulation

Understanding the EU Medical Device Regulation

In this eBook, learn about the 2020 European Union (EU) Medical Device Regulation (MDR), the expanded scope compared to previous regulations, the challenges it poses to medical device companies and how to overcome those challenges. A comprehensive understanding of your requirements will help your company succeed in an evolving landscape and prepare for future changes.

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What Is the EU MDR?

Managing Requirements Under Section 10.4 of the EU Medical Device Regulation

Section 10.4 of the EU MDR introduces a broad range of complex requirements for companies to navigate. This guide will help your company understand these requirements, and how your existing substance data and processes will be impacted.

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Baxter & Assent Compliance

As Baxter prepares for the European Union (EU) Medical Device Regulation (MDR) deadline, we’ve chosen Assent as a strategic partner. With Assent’s expertise and platform solution, we have been able to leverage technology to streamline the collection and management of our EU MDR data in a cost-effective way.

Wilhelm J. Janisch, Baxter
Healthcare Corporation

$10.56 billion USD medical device company

Fortune 500 company

Headquarters in Deerfield, IL

The Assent Solution for Medical Device Companies

Find out how Assent’s expertise and industry-leading solutions help medical device companies navigate the evolving compliance landscape and leverage their supply chain data.

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MARCH 27, 2019

Recertifying a Product Under the European Union Medical Device Regulation

POSTED BY

Raj Takhar

In September 2012, the European Union Medical Device Regulation (EU MDR) 2017/745 was first proposed to address weaknesses in the existing Medical Device Directive, which came into force in the 1990s. The new regulation expanded the products in scope, as well as the list of regulated substances.

In September 2012, the European Union Medical Device Regulation (EU MDR) 2017/745 was first proposed to address weaknesses in the existing Medical Device Directive, which came into force in the 1990s. The new regulation expanded the products in scope, as well as the list of regulated substances.Companies have until May 26, 2020, to certify new devices. Devices that were previously certified under the MDD will need to be recertified to meet the new requirements of the EU MDR.

Devices used for cosmetic purposes, which weren’t regulated by MDD, will now require certification under the EU MDR. In total, more than 500,000 devices will now be in scope of the regulation. The EU MDR timeline is aggressive, but proactive compliance can help ensure continued market access, protection from enforcement action and a decreased risk of reputational harm.

How to Recertify a Product Under EU MDR

Products that currently have CE markings from MDD certification will need to be recertified under the EU MDR. Over 300,000 medical devices will require recertification in order to maintain market access. The deadline for each device is dependent on the expiration date of their former certification. However, the certification process is the same for all devices, and it is highly recommended that companies begin immediately. In order to recertify a product under EU MDR, a business must:

  1. Determine the classification of the device.
  2. Create a technical file that includes detailed information on the parts involved, the purpose of the device and any testing that has been carried out.
  3. Ensure a Quality Management System (QMS) is in place to manage product design, product manufacturing and change requests.
  4. Submit the device for approval by a notified body along with the QMS and technical file data

Approved devices will receive a Declaration of Conformity, after which they can be registered on a central database for medical devices, receive CE markings and be placed on the European Economic Area (EEA) marketplace.

Steps may vary according to the classification of the device, but every application will require a technical file. This involves a great deal of data collection from a company’s supply chain and can take months to complete.

Meeting the EU MDR Timeline

The regulatory bodies that will be responsible for EU MDR certification are still forming. Companies that are in scope of EU MDR should expect a backlog, as thousands of applications must be examined and certified. The deadline for devices looking to enter the EEA market is May 26, 2020. However, new class submissions should happen well in advance, with data collection for technical files starting immediately.

Companies that received MDD certifications for medical devices must have EU MDR certificates before the MDD certificates expire to ensure business continuity. All devices require EU MDR certifications no later than May 26, 2024. Larger companies should expect the technical file to take over a year to complete.

How Assent Can Help You Recertify a Product Under EU MDR

The Assent Compliance Platform is the leading supply chain data management solution, and allows companies to efficiently collect, organize and analyze data from across their supply chains. Our Chemical Reporting Module, part of the platform, enables efficient and accurate EU MDR data collection and management, which is vital to successful certification.

To learn more about how Assent can help you stay compliant with the EU MDR, contact us at [email protected].

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Learn how Assent can support your data requirements under Section 10.4 of the EU MDR today.

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