If something goes wrong with a medical device, there’s no quick and easy fix. What starts with a costly product recall can end in lawsuits – and unhappy investors. Reimbursement by health insurance companies can be lost when non-conformities are not addressed in time. In healthcare, the only way to keep every stakeholder safe from physical, reputational, and financial harm, is through strict adherence to medical device regulations.  That’s why, at Peercode Regulatory Consultancy, we’re passionate about helping medical device companies stay compliant with regulations like the EU’s MDR.

Ongoing transparency and responsibility 

Regulations in the EU put the responsibility for device safety squarely on the shoulders of manufacturers. It’s their job to ensure regulatory conformity over the full life-cycle of a product and have control over their own supply chain – whether services, components or products are sourced from inside the EU or elsewhere in the world.

Responsibility for product safety doesn’t end with certification for the EU market. That’s just the beginning. Post Market Surveillance (PMS) ensures it stays safe once it’s there. After all, no company wants a scandal. But that’s exactly what can happen when a medical device company switches out medical-grade components for nonmedical ones, or fails to act on user feedback. What seems like an easy way to cut costs can have significant consequences for people’s health. 

That’s why thorough and continuous monitoring and testing of medical devices and their purchased components is necessary, and also why any significant change needs to be documented and submitted to a Notified Body. Whenever there’s a change to the type of material used – such as the metal for an internal plate – it needs to be fully tested to ensure the highest possible product and patient safety.

Balancing innovation with product safety

The medical device industry is highly-innovative, giving authorities the mandate to tighten regulations and prevent rogue or harmful products from entering the market. High-profile cases of faulty or dangerous products, such as the PIP scandal, certainly influenced the EU’s drafting of the MDR, closing certain gaps and clarifying ambiguities in the previous EU Medical Device Directive (MDD). 

Not all risks can be immediately seen. For that reason, product safety is an ongoing process that has to sit front and center of any post-market strategy. Sometimes unforeseen risks will arise, but companies can cover themselves by doing all they can to identify and mitigate those risks as early as possible. 

Regulations are always playing catch-up with new products and technologies – Artificial Intelligence is a current example. Put simply, highly-innovative environments need good regulations. Without regulations, the market can quickly spiral out of control and, in this case, endanger patient health. 

Stronger accountability means better outcomes

Everyone wants safe devices on the market. But when it comes to compliance, perceptions are everything. Pharmaceutical products get actual approval for the market, whereas medical devices get confirmation of conformity with a checklist of requirements. This almost certainly influences perceptions around their importance. 

However, the EU’s MDR has made it clear where the accountability lies. Manufacturers need to cover every base, from their suppliers to their distributors. All of these parties are mentioned in the MDR, ensuring the entire chain conforms. At the same time, companies have a duty to keep track of the latest developments in their field via post-market surveillance. This helps them to maintain awareness of the latest and safest state-of-the-art developments – and their product’s compatibility with those developing standards.

For us, at Peercode Regulatory Consultancy, we see the importance of compliance with medical device regulations to every stakeholder in the healthcare system. Patient and physician safety must come first. When it does, companies and their investors also stand to benefit.  

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