The EU Medical Device Regulation: Five Reasons to Stay Compliant

The EU Medical Device Regulation: Five Reasons to Stay Compliant

Companies are still figuring out how to manage their requirements under the European Union Medical Device Regulation (EU MDR) 2017/745, and in-scope medical device manufacturers have until May 2020 to update their product compliance programs.

The legislation regulates the usage of some substances proven to be carcinogenic or mutagenic above a threshold of 0.1 percent weight by weight (w/w). It also applies to substances that have been found to be toxic to reproduction or to have endocrine disrupting properties, as identified by the EU Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation. If your product exceeds threshold on a restricted substance, you must justify its usage in the product approval process, and label the packaging to warn consumers of associated risk.

Time is running out for companies to prepare for enforcement of the regulation. Those in scope can either deploy a targeted send-out to suppliers, or acquire data on the full composition of their products. This will provide the data needed to determine whether products contain restricted, over-threshold substances.

The regulation presents a great deal of risk to companies in scope, which have several reasons to give these requirements their proper due, including:

1. Product Recalls

This is the big one, and represents the bulk of the damage your company could incur as a result of non-compliance with the EU MDR. If your products contain substances over threshold, you must cooperate with the approval and labeling process to keep your products on the market. If products shipped into the EU region after the MDR goes into effect are found to be harmful, they will be pulled from shelves and stock room floors immediately, at cost to your company.

Assent’s Chemical Reporting Module helps companies manage their EU MDR requirements. Click here to learn more.

2. Loss of Market Access

Failing to keep your products compliant with the EU MDR will prevent you from gaining access to EU markets. If you’re selling into the region, you should be prepared to produce the necessary compliance documentation. Otherwise, your goods could be impounded or turned back at the border. This can lead to contract loss, forced and costly product redesigns, and more.

3. Adverse Media

The media is growing increasingly diligent at holding companies accountable, especially in the areas of non-compliance and product safety. Manufacturers in the medical device industry are particularly susceptible, since the products are directly associated with human health. If your company is found to be selling products that are regulated by the EU MDR but do not comply with the quality management system, medical device approval process and labeling requirements, adverse media reports could surface. Depending on the size of your company, this might cost anywhere from $90–130 million in financial damage.

4. Risk of Human Harm

Due to direct contact with human beings, both inside and out, medical devices can cause harm to the health of the very people they’re built to help. If a person is harmed as a result of contact with a medical device, it can lead to a major product recall events and/or lawsuits costing between $1.5–3 billion.

5. Lost Access to Substances & Materials

If the substances you need to manufacture, maintain or repair a product become regulated in the future, this could present business continuity risk, potentially disrupting the availability of critical components and materials. This can interfere with production lines, and your ability to provide repairs, accelerating your product into the end-of-life stage before its time.

Assent’s Product Compliance Suite helps companies collect substance data to comply with regulations, such as the EU MDR. You can take preemptive action against future regulatory expansions by collecting full material declarations for any parts and substances used in the process of manufacture.

Specifically, Assent’s Chemical Reporting Module helps companies collect and manage supply chain data to maintain market access and reduce risk associated with the EU MDR. To learn more, email