United States-based medical device manufacturers must comply with regulatory requirements to take devices to market. Following requirements in the US is one thing, but what if your device is sold in the European Union (EU)? New regulations have been anticipated to replace the original Medical Device Directive (MDD) which regulated medical device production and distribution in the EU. And they’re finally becoming a reality all manufacturers selling into the EU market must understand and comply with.
What is the EU MDR?
The EU Medical Device Regulation (MDR) is a set of regulations to oversee medical device production and distribution in Europe for the protection, health and safety of EU citizens. Any medical devices sold throughout the EU must comply with EU MDR regulations.
Is EU MDR different than MDD?
The MDD was the original set of regulations established in 1994 to govern medical device production and distribution in the European market. It spanned not only devices, but also products and software as well. This framework acted as guidance for medical device manufacturers to comply with European standards for how products were assessed, manufactured, and distributed. The MDR is the next evolution and went into effect on May 26, 2021 (only to be postponed to 2024). It ensures medical devices are safe, and of good quality. They must meet requirements for EU medical devices and be indicated by a CE mark.
New requirements include the following devices:
- Certain devices with no intended medical purpose
- Reprocessed single-use devices
- Devices for disinfection, sterilization, and cleaning
- Devices incorporating non-viable human tissues
- Ancillary medicinal products
- Active implantable medical devices
It makes it easier to remember that nothing in the original MDD has changed. MDR has simply expanded its requirements. For example, MDD articles have increased from 23 to 123 in MDR. Annexes increased from 12 to 17, and rules from 18 to 22.
How does it impact medical package testing?
If you sell medical devices into the European market, you should be aware of its impact to packaging. The MDR has a lens on risk, packaging, labeling, and microbial sterility. The following are a few highlights to keep top of mind:
You will likely have to retest your products, including legacy devices you’ve had on the market for years. Initial assessment and testing weren’t as robust then as they are now. The key to addressing this issue is to look through all product families and conduct a gap analysis to identify what the MDR is asking for. Be prepared for the MDR requirements to be different enough that validating a single product from a product family won’t be enough the way it used to be.
Transportation and storage
Risk is a big part of the new MDR. Manufacturers will have to minimize risk to patients and they will have to prove it. A key aspect of that is transportation and storage. Medical device characteristics and performance must hold up to the inevitable conditions they will be exposed to, whether on the shelf or in transit. Distribution simulation testing and aging testing were likely done on your devices already. But what if product changes have occurred? Testing may need to be performed again to meet MDR regulations.
Remember ISO 11607-1 and 11607-2
In the planning and execution of product or packaging changes to meet the MDR, manufacturers cannot forget to continue adhering to ISO 11607-1 and 11607-2 standards. We recommend you check to see if your validation was performed, or had a weak outcome, then validate to MDR standards. You can start with a gap analysis between 11607 and the new MDR. Be sure to include strengths and weaknesses in packaging validation: distribution simulation, aging validation, shelf-life validation, and heat seal validation. You should retest if any questions linger.
Don’t fall behind
The MDR officially goes into effect in May 2024, meaning all medical devices in the European market must be compliant by that date. That may seem like plenty of time. It may be tempting to put your MDR due diligence on the backburner. Don’t make that mistake. Shelf-life testing can often take up to four months to complete. Large companies with hundreds (or more) of products have to anticipate the time it will take to obtain all medical package testing for their devices. Companies of all sizes, no matter how few or how many medical devices they have, should begin their MDR medical package testing right away.
Be MDR compliant with confidence
Don’t be caught unprepared as we hurtle toward the EU MDR 2024 deadline. Taking steps right now to meet EU MDR requirements is the best course of action, as is working alongside a partner who understands the new regulations and can help you meet them with confidence. Contact Life Science Outsourcing today to discuss the quickest, most compliant way of testing your products and ensuring they meet the new MDR. We are your partner through this process and bring decades of validation experience to your project, whether for FDA or EU, or internal edification. We are your number one resource for all your medical package testing needs.