The COVID-19 pandemic has affected us all these past few months and presented many new challenges for the medical device industry. For package testing, we have seen delays in getting samples shipped to our laboratories due to interruptions in the supply chain. Many MDMs also were forced to put some projects on hold due to hospitals not doing elective surgeries and to save costs. We are starting to see many of these projects come back now that things are slowly opening back up.

Another thing impacted by COVID-19 is the deadline to comply with the EU MDR. As due to COVID-19 and other factors, it was recently announced that the date to comply with EU MDR has been pushed back a year to May 26, 2021. Prior to COVID-19, many MDMs were scrambling to finalize package validations to meet the original deadline set to go into effect in May 2020.

As a reminder, the new EU MDR regulations were put in place to increase medical device safety and effectiveness in the EU Market. Thus, for a manufacturer to continue to sell its device in the European Union, a CE mark indicating certification to the new MDR must be in place by the updated deadline.

The regulations feature several significant changes that affect packaging and labeling requirements. Packaging is still considered an accessory to a medical device under MDR, as it was under the previous directives, and package validations are performed according to ISO 11607. Most legacy devices will need to redo their packaging validations, particularly transportation distribution testing, in order to prepare the documentation now required under the MDR that was not required before.

What does this mean for you?

• Become familiar with EU MDR. While you should have started by now on it, if you have not, the time to start is now. For despite the deadline being moved back another year, given the extensive amount of work that you will need to do between now and then, if you do not start now, you likely will not finish.

• Do a gap analysis to determine what previous package testing was done on a device prior to its approval under the previous directive. Then identify the types of new test data that will be necessary for MDR compliance. At a minimum, you will likely need to redo transportation testing on your device, so that will likely be the best place to start.

• Read and familiarize yourself with ISO 11607 so you understand your validation responsibilities.

• Get your package professionals involved. Packaging professionals should be working with colleagues in regulatory, product development, and quality as early as possible during medical device development. Also, during product design verification, conduct feasibility testing to understand the product and package interactions.

• Perform a risk assessment of the medical device you are packaging. Determine the specified attribute data for your package, identify all potential failure modes that could cause (or result from) an out-of-specification package, and then determine the sample size needed to catch those failures. The chosen sample size and resulting confidence level will depend upon the overall risk assessment (Failure Mode Effects Analysis; FMEA) that the MDM puts in place for any given device.

• Talk to your suppliers and service providers. Your vendors have a lot of knowledge. Get as much data as possible from material providers, thermoformers, package converters, and machinery providers. Finally, work with a qualified and knowledgeable test laboratory that understands the regulatory requirements, and can further guide you to assure you meet specific regulatory requirements.

• Write your packaging protocol and establish clear acceptance criteria. Your protocol should have the following: a purpose, a scope, areference section listing all standards and test procedures, descriptionsof all materials and equipment, all attribute data, a sequence of eventsor a flow chart of what will transpire, and a summary of the chosen sample size and acceptance criteria. It is important to document everything, as the protocol can help you manage your processes with outside vendors.

• Know your worst cases. Review your product families to define all worst-case scenarios. It is a hard question to answer, but you are looking for what potentially can cause the most adverse effects to the package.

In the end, medical device professionals need to understand what they are putting into packages. If you do your homework with materials and processes and understand what you need to do before validation, you will build a successful package validation program that meets the EU MDR requirements.

DDL has provided package, product and materials testing for the medical device industry since 1990. An ISO/IEC17025 accredited, third party testing laboratory, we employ a team of engineers, technical and quality experts devoted to helping our customers bring medical, pharmaceutical and consumer products to market. For more information, or to answer any testing questions you may have,
please contact DDL or call at (800) 229-4235.

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