New SVHC Requirements Are Coming — Are You Ready?

Existing programs designed to collect Substance of Very High Concern (SVHC) data for the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation are not enough to meet new EU Waste Framework Directive (WFD) requirements. The new Substances of Concern In Products (SCIP) database requires companies to gather more data than ever and submit this information to ensure compliance or face severe fines and even loss of market access.

The SCIP Database & How It Affects You

Designed to support the ongoing effort to establish a circular economy, the SCIP database gives waste operators and the public access to information about the presence of SVHCs in products and waste materials. If your company manufactures, imports or sells products containing these substances within the EU, it must submit information to the SCIP database by January 5, 2021, or face severe regulatory enforcement. Learn more about the requirements facing your company in our eBook, The Waste Framework Directive & SCIP Database Reporting.

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Learn More About New SVHC Reporting Requirements

Scope Your
Supply Chain

Building a comprehensive SCIP program is a major requirement for organizations in the EU and beyond. Companies that have not begun to collect data must begin to do so immediately, as failure to submit by January 2021 exposes companies to severe regulatory risks. Discover best practices for scoping products in your supply chain, engaging your suppliers and determining the steps you need to take to ensure your company can meet its SCIP database requirements in our guide, Building a SCIP Database Program.

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Save Time & Resources With the Leading Supply Chain Data Management Platform

Assent’s leading platform ensures businesses meet their EU WFD and SCIP database requirements before the deadline. Our automated solution for supply chain engagement mitigates the risks posed by evolving regulatory requirements while freeing up time and money to allow companies to dedicate resources toward key, revenue-generating business initiatives. Learn more in our guide, The Assent Solution for the Revised EU Waste Framework Directive.

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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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