Medical Device Regulatory Intelligence – What is Required?

Medical Device Regulatory Intelligence – What is Required?

With regulatory requirements ever evolving and the stringency of medical device regulation, it is no wonder that the complexities are confusing when it comes to regulatory compliance.  But what do you understand when it comes to Regulatory Intelligence (RI)? For lower risk devices such as class I non-sterile, the RI should be pretty straight forward but what about higher risk devices such as a class III implantable device with a software application?  Using Regulatory Intelligence to implement your strategy can decrease time to market, reduce costs as well as ensure compliance.

Regulatory Intelligence in the medical device industry is also known for employing small teams, so these professionals often have a lot to do with few resources. The challenge is not only keeping up with changing standards, but also staying on top of a huge amount of information.

As a medical consultancy we understand the challenges that manufacturers face in keeping up with all the various sources of regulatory intelligence such as, standards, global regulations, guidance’s and industry news.  Dependent on the size of the business and resource, will determine the commitments the regulatory professional will have, as well the availability they have to carry out Regulatory Intelligence activities.  With advances in information technology there is an overload of information becoming readily available at an ever-increasing speed, from multiple different sources, making it difficult to keep up to date.

What is the Definition of Regulatory Intelligence?

Firstly, how is Regulatory Intelligence defined?  To put it simply, it is defined as a systematic process of collecting, analysing, and disseminating information about regulatory requirements, policies, and guidelines that affect the development, manufacturing, distribution, surveillance and regulation of medical devices.

Monitoring Changes in Medical Device Regulation

Before being able to adapt to any regulatory changes, you need to know about them first and that’s where Regulatory Intelligence comes in.  Regulatory Intelligence starts with understanding the current regulatory landscape and what changes may be on the horizon, but what are the main stages and what should you be looking for?

What are the Main Stages of Regulatory Intelligence Activities?

 

What Information Should be Included for Regulatory Intelligence?

The regulatory content collected should contain the following information;

Challenges in Developing a Comprehensive and Robust Regulatory Intelligence Framework

Below are some examples of the potential challenges manufacturers face in tracking, compiling and reviewing regulatory information.

  • Adapting and keeping up to date with rapidly changing and complex regulations.
  • Uncertainty and access to regulations in emerging markets.
  • Spending too much time researching regulatory requirements for different countries.
  • Regional legislations are often in its local language.
  • Insufficient coordination and compilation of information from multiple functions to understand the bigger picture.
  • Unstructured information resulting in Regulatory Intelligence not being used appropriately.
  • Lack of a centralised mechanism to capture Regulatory Intelligence.

 

Final thoughts…

Regulatory Intelligence plays a vital role in keeping up to date with the ever-changing regulatory requirements in the regions they are sold, as well as any changes in the medical device industry that may impact those devices.

Having the right expertise and knowledge, regulatory professionals and technology play an essential role in the successful execution of Regulatory Intelligence and the overall goal to make safe devices available globally.

Still unsure what to do? LFH Regulatory can help…

If you have any questions or need help with Regulatory Intelligence, please get in touch with our medical device consultants today, who have expertise in global regulatory landscape by phone +441484662575 or via info@lfhregulatory.co.uk. Alternatively, you can also simply complete the ‘Contact Us’ section below to see how we can help.

Written by Laura Friedl-Hirst, Managing Director and Principal Consultant. Laura has over 12 years of experience within the medical device and IVD industry, working with a vast range of product types, which include SaMD, custom-made, active and implantable devices. She has expertise in regulatory affairs, quality assurance and clinical evaluation writing.

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