For manufacturers, missing supplier information is the main cause of lost sales and product recalls. Medical device companies will face increased risk when the European Union (EU) Medical Device Regulation (MDR) comes into force in May 2021. Have your products been certified?
Goods can be withheld for many reasons, but it usually happens when a border, market surveillance, or regulatory enforcement agent checks for compliance documentation at import. If your product is non-compliant with one of many market access regulations, it could prevent you from selling your products or even send you back to redesign. These include regulations include the:
- EU MDR.
- Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) Regulation.
- Restriction of Hazardous Substances (RoHS) Directive.
Although manufacturers have been navigating REACH and RoHS for many years, most have yet to gain certification for their products under the new MDR. This is a problem, as the May 26, 2021, deadline is approaching quickly.
What Is EU MDR Compliance?
The EU MDR was passed on April 5, 2017, replacing the EU Medical Devices Directive (MDD). It was introduced to mitigate the negative health impacts associated with hazardous substances in medical devices. It establishes more stringent requirements to ensure that products placed on the EU market won’t negatively impact human health or the environment.
Section 10.4 of the regulation obliges manufacturers to report on the composition of their products, and verify the presence of any of 1,200 substances limited to a threshold by the EU MDR. In cases where a product contains a hazardous substance identified by the regulation, manufacturers need to limit its content to a safe threshold, relative to the use case of the substance.
Following the identification of an MDR-related chemical substance, manufacturers are advised to follow the processes identified within the European Commission Scientific Committee on Health, Environmental, and Emerging Risks (SCHEER) guidance on phthalates. The guidance outlines the process of examining the use of alternative substances and justification for using the identified MDR chemical substance.
Following the SCHEER guidelines will help you populate your technical file with the appropriate documentation to gain the appropriate MDR certification from a notified body. Upon approval, manufacturers may then apply for the CE marking and place the product on the EU market.
The UK Medicines and Medical Devices Bill 2019-21 will be implemented in 2021 to align the reportable substances in the UK with the EU MDR substances list. Products approved by a notified body will follow a simplified registration process to gain access to the UK marketplace. Companies will need to follow the same EU MDR approval process through an EU-based legal entity.
Download our guide, Building an Effective EU Medical Device Regulation Program, to maintain access to the EU and protect your sales from missing supplier data.
Enhancing Quality Management for Compliance With the EU MDR
In order to comply with the EU MDR and align with guidance issued by the European Chemicals Agency (ECHA), manufacturers need to enhance their quality systems, and introduce new procedures for document storage, post-market surveillance, and risk assessments for their products, as defined in ISO 13485. These include:
- Quality objectives.
- Business structure.
- Procedures for engineering design control.
- Verification, validation, and review of technical files.
- Product testing, trials, and verifications.
These enhancements should produce the high quality data needed to gain the CE marking. It is also important to note that while notified bodies will review your product composition data to provide certifications, they will also review your quality management system to ensure data quality and accuracy, and make recommendations for remediation (if necessary).
Why Is EU MDR Reporting Important for Manufacturers?
Failing to meet the EU MDR’s requirements can lead to a range of negative impacts. These include fines, litigation, product recalls, design change, and lost access to materials and markets. And with enforcement agencies targeting more companies every year, compliance is crucial. If your products are taken off the market, and the media publishes a public report, you could receive additional financial damage as customers choose products that look like safer alternatives.
Meanwhile, if your company cannot show its efforts to mitigate these risks and implement new supply chain data and quality management systems, you may face setbacks such as:
- Investment loss.
- Fines and penalties.
- Unsalable overstock.
- Lost access to materials.
- General reduced profitability.
- Additional regulatory oversight.
- Damage to reputation and credibility.
Manufacturers must take a transparent, proactive approach to mitigating these supply chain risks — and the EU Market Surveillance Regulation (MSR) makes compliance with the EU MDR even more crucial. Coming into force on January 1, 2021, the MSR introduces new powers for EU enforcement bodies to track down products placed on the EU market that may not be compliant with approximately 70 EU regulations.
How Assent Compliance Can Help
In order to comply with these regulations, companies are implementing supply chain data management systems to manage and verify data integrity, and centralize it for all departments within your company. This can create process efficiencies across your business. For example, it can eliminate discrepancies in product labeling, safe use instructions, and web site content, providing all users with a single source of truth.
Assent’s EU Medical Device Regulation solution is helping companies get ready to meet the May 26, 2021, EU MDR deadline by automating the collection of product composition data for Section 10.4 of the legislation. Our data, regulatory, and supply chain expertise can help you share this information with notified bodies and enforcement to meet the requirements of this stringent legislation.
For more information about how Assent can help, contact our experts.