The SCIP database was legally mandated by the EU WFD, which requires companies with articles containing SVHCs to make and update SCIP notifications. Understanding what’s being asked of you is key to being prepared for your new SCIP requirements. Learn more — including the requirements for non-EU businesses — in our eBook, Understanding the EU Waste Framework Directive & SCIP Database Reporting.
Managing SCIP requirements without a solution will cost time and money and often results in errors that will make your company non-compliant. Watch a SCIP submission process and you’ll understand how Assent removes obstacles and saves valuable resources for you and your team.
Gathering supply chain data is the most expensive and time-consuming part of a SCIP program. Since submissions aren’t one-time requirements, companies must budget for ongoing compliance or risk enforcement action. Read our guide, Building a SCIP Database Program, to discover cost-effective practices for collecting and managing your supply chain data that will ensure your company can meet its SCIP database requirements.
Assent’s experts were a part of the development of the SCIP database. Combining this expertise with our leading platform technology and system-to-system database integration, Assent’s solution will establish your company as a leader in compliance. As EU WFD enforcement grows and customer requests for data increase, you can turn your program into a competitive advantage. Learn more in our guide, The Assent Solution for the Revised EU Waste Framework Directive.
Unsure if you have an obligation to make a SCIP database submission? Use our SCIP Digital Scoping Tool to find out and start preparing your programs.
As established by the EU Waste Framework Directive, you must submit to the SCIP database no later than January 5, 2021, or risk enforcement action. Assent can help you get the data you need to file your submission or act as a EU Legal Entity and file on your behalf. To learn more, speak to one of our experts.
You are currently out of scope of the EU Waste Framework Directive, but the scope expands with every change to the REACH SVHC Candidate List and data fields. You can monitor those changes by subscribing to our newsletter.
Respond to any regulatory requirement in less time and using fewer resources. Learn more in our guide.
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With no SVHCs above threshold, you do not have an obligation to submit to the SCIP database. The SVHC list changes bi-annually which could bring you into scope at a later date. Stay on top of evolving SCIP requirements by joining our newsletter.
You will receive requests for data from your EU customers as they rush to meet the January 5, 2021 deadline. Assent can act as your EU Legal Entity and submit data on relevant parts to the database. This can provide you with an efficient way of quickly meeting those requests so you can maintain a strong relationship with your customers. To learn more, speak to one of our experts.
Fill out this form to download your copy of Centralizing your Program with The Assent Compliance Platform.
On January 5, 2021, the Substances of Concern In articles, as such and In complex objects (Products) (SCIP) database will go live. Companies operating in the European Union (EU) must submit data when introducing articles containing Substances of Very High Concern (SVHCs) above the 0.1 percent weight by weight (w/w) threshold.
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:
- Determine the classification of the device.
- 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.
- Ensure a Quality Management System (QMS) is in place to manage product design, product manufacturing and change requests.
- 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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