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How to gain compliance under EU MDR as quickly as possible

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Sandi Schaible, senior director of analytical chemistry and regulatory toxicology at WuXi Medical Device Testing, explains how manufacturers can gain compliance under EU Medical Device Regulation (MDR) as quickly as possible.

Who do manufacturers need to bring to the table in these testing discussions, to make the planning process as efficient and expeditious as possible?

A successful testing plan starts with the right team supporting it. With added pressure on the market, it's essential to ensure your assembled team knows their products backwards and forwards. Ideally, this is a cross-functional team spanning marketing, research and development, operations, and quality.

Involving a knowledgeable and experienced product manager can help streamline the planning process. Other vital roles to engage during the planning process include design engineers who are familiar with the ins and outs of the product design and functionality, as well as manufacturing engineers and potentially a production manager who can discuss the manufacturing process and any additives that may have come in contact with the product.

Your team should also consist of people knowledgeable on sterilisation, packaging, and labelling. Involving experts in these areas will help create a comprehensive product testing plan.

What can manufacturers do to help streamline the testing process with their selected testing lab?

Be communicative and bring all product information with you to the table - you can never provide too much information to a testing lab. Collecting and assembling information is an essential first step, and the critical second step is sharing it. It may seem like a testing lab is asking for an excessive amount of information, but these details can make or break a testing plan. Time is of the essence, leaving no room for errors or missing information.  

Some areas to be prepared to discuss about each device include:

What hurdles should manufacturers be aware of while developing a testing plan?

The two most significant hurdles manufacturers face in developing a testing plan have to do with legacy devices and regulatory knowledge. Legacy products that need supplemental testing before approval present unique obstacles of their own. To move forward with testing, manufacturers now must provide additional device information that was not previously required.

Staying up to date with regulatory requirements also continues to be a hurdle, as expectations are still evolving. In the coming months, notified bodies will continue to gain experience enforcing standards and will likely begin to ask even tougher submission questions. Additionally, other governing bodies continue to release standards advancing the requirements with which manufacturers must comply. We've seen this with the update to ISO 10993-18, which enforces more stringent identification requirements for chemical characterisation studies. If you can't hold a testing lab accountable to these levels, you may face backlogs in your testing plan. Don't let your guard down - watch for regulation changes even after the deadline has arrived, and work with your selected testing labs who can also help you stay informed and up to date.

Conclusion

If you're facing pressure to get back on track with your compliance efforts, you're not alone. Use this advice to reduce the risk of setbacks. Reassessing your testing plans is the first step to getting your device approved as quickly as possible. From having the best team in place to ensuring your testing partner has the necessary capabilities to support your success, do your due diligence to get yourself back on track for a successful submission.  

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