Medical Device Regulations and In Vitro Diagnostic Regulations – How to Prepare for the Fast-Approaching Deadlines

The deadline for compliance with the EU Medical Device Regulations is looming. On the 25th of May 2017, new EU regulations for medical devices and in vitro diagnostic medical devices entered into force, giving medical device companies a 3 / 5 - year transition period to achieve compliance. Whilst the MDR has been delayed as a result of the COVID-19 pandemic, by May 2021 medical devices must adhere to the updated regulations, transitioning from the Medical Device Directive (MDD) to the Medical Device Regulations (MDR). The implementation of the In Vitro Diagnostic Regulations (IVDR) follows shortly, after a 5-year transition period, in May 2022.

The fundamental aim of the MDR and IVDR is to afford greater transparency to both the customer and authorities by creating a reciprocal flow of information. This is achieved by placing the focus on post market surveillance, as well as the creation of a European database to track devices.

The resulting efforts can range from minor technical documentation amendments to implementing quality management systems and undergoing clinical investigations. Ensuring that total compliance is achieved is an essential – but extensive – task for the manufacturers and distributors of medical devices. Making the necessary modifications may demand a vast amount of time, resources, and most importantly, a high level of understanding. Contract research organisations (CROs) can be hugely beneficial during this process, drawing upon experts with extensive backgrounds in these regulations to collaborate with customers, making sure their devices become, or stay, compliant.

At LINK Medical – a well-respected and highly regarded CRO – we bring a dedicated and skilled team of consultants to every project, offering optimal solutions in areas such as clinical development, quality assurance, medical device regulations and many more. With a large regulatory team in Northern Europe, as well as experience in facilitating the MDR shift for several global medical device companies, we are an ideal strategic partner to help businesses bring their devices in line with the latest regulations. As a full-service provider, we can deliver guidance every step of the way, tackling each and every hurdle our customers may face, while tailoring support according to their needs.

First, our team at LINK Medical can perform a thorough gap analysis to detect any deficiencies within our customers’ technical documentation or QMS – a vital step to determine where changes must be made to adapt to the regulations. For other clients it may be more appropriate for members of our team to provide short, hour-long, or full day training sessions, outlining what the new regulations entail, and how to follow them. Beyond this, we can help to implement any changes to overcome detected gaps in their documentation.
To conform to the latest safety and performance requirements of the MDR, clinical data is vital. In order to meet this demand, we specialise in the provision of clinical development plans to ensure the clinical data adequately supports the product claims. Information security is also an important aspect of the updated regulations; our focus on technology allows us to implement processes for rigorous data handling in order to prevent information loss or unauthorised access.

Updating medical and in vitro device documentation to meet these new regulations requires a considerable amount of work and time, regardless of the size of your company. Smaller companies may lack the resources or a qualified person on-staff to tackle these new regulations. Larger companies may staff quality assurance personnel for day-to-day regulatory work but updating documentation to satisfy these new regulations can be a large undertaking within the time constraints. Partnering with a CRO can streamline your device through this complex regulatory process, ensuring that documentation is fully updated without adding any strain. As clients often differ in the support they need, we can offer these services on a case-by-case basis, providing more than a one-size-fits-all approach.

What makes LINK Medical stand out as an ideal partner is not just our knowledge of these regulations, but the constellation of expertise we provide across the industry – we are always happy to answer questions that extend beyond MDR and IVDR. Our flexible approach means that manufacturers,distributors and importers of medical devices alike can benefit from LINK Medical’s unique combination of expertise in specialist areas.

By Maria Kastenfalk,
with collaboration from our Medical Device team!

Contact us today to learn more about how our expert Medical Device team at LINK Medical can help you with the upcoming deadlines for compliance within MDR and IVDR. or visit our website

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