Adapting to Changes in the European Union REACH Regulation

The Impact of the REACH Authorisation & Restricted Substances Lists

The Authorisation and Restricted Substances lists are key components of the European Union (EU) Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation, and companies that know how to navigate these lists will be better prepared to respond to the requirements laid out by REACH.

Download Assent’s Understanding the REACH Authorisations & Restricted Substances Lists whitepaper to learn more.

Download

New Reporting Requirements for
Articles Containing SVHCs

Maintaining REACH Compliance in 2020
& Beyond

REACH requirements have continued to evolve since the regulation came into force in 2007, and companies’ obligations are expanding. Download our guide, REACH in 2020 & Beyond, to gain a clearer picture of future changes to the regulation, and what companies must do to maintain compliance in the years to come.

Download

Assent's Product
Compliance Suite

As the regulatory landscape expands, companies need a solution that can help them efficiently manage their requirements. Assent’s Product Compliance Suite offers industry-leading tools to help companies comply with numerous regulations, including EU REACH. The REACH SVHC Module enables companies to meet their requirements, and maintain EU market access.

Download

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].

See MoreSee Less

Learn how we can help you increase the efficiency of your REACH program today.

Book a Demo