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Staying on top of regulatory obligations in the medical device industry

With EU MDR 2021 deadline fast approaching, many organisations are stretched thin in their attempt to meet the changes to the vast number of Standards and regulations. While achieving compliance before the deadline is essential, many companies within the medical device industry may find themselves in trouble in the months following.

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Staying focused on the long-term approach

Keeping on top of your regulatory obligations and staying compliant should be a long-term focus. Just as medical device organisations have devoted specific resources and time into a strategy to meet the short-term deadline of EU MDR 2021, organisations should also prioritise in a long-term strategy of maintaining compliant. Meeting these requirements should be a strategy that is 'always on', not intermittent.

Importance of regulatory obligations throughout every step

Medical device (MedDev) companies often require regulatory guidance in departments or development project teams regarding the design, development, evaluation, or marketing of products. Companies also invest in developing regulatory strategies and implementation plans for the preparation and submission of new products. These activities all take place over months, even years, and require strategic effort and dedication to meeting regulatory obligations.

Failure to stay compliant with the relevant Standards (such as ISO 13485:2016 Medical devices - Quality management systems - requirements for regulatory purposes) and meet the relevant regulatory obligations can have dangerous and even lethal consequences due to the nature and use of medical devices. For both those working in the MedDev space and the end users, there is no room for error. 

As the MedDev industry is inherently high-risk, a comprehensive risk management system must be implemented to guarantee all efforts have been made the minimise risk as much as possible. ISO 14971:2019 is the new edition of a crucial Standard in the industry. This Standard details the application of risk management for medical devices, and provides guidance on how risk should be assessed, analysed, monitored, documented and controlled to protect both the end user and the manufacturer.

The new edition aligns with the new EU MDR and EU IVDR performance requirements and provides a risk-management framework for the medical devices industry from start to finish, providing a long-term and 'always-on' strategy that will help your organisation meet regulatory obligations.

Regulatory challenges faced in the medical devices industry

In this demanding environment, those handling regulatory affairs face constant challenges. Some of these challenges include: 

  • Finding the Standards necessary to meet not only the regulatory obligations of the country being manufactured in, but also of all the countries being exported to
  • Receiving information on changes to Standards and tracking the exact changes of the newest Standard compared to the previously used version
  • Collecting all the relevant Standards that are important for a specific product group
  • Staying informed on new regulations as they are published
  • Maintaining reporting on regulatory requirements in an efficient and timely manner

How to stay ahead of your regulatory obligations 

Continuing to meet your regulatory obligations means ensuring that your organisation is always using up-to-date and current Standards. Intertek Inform's digital platform i2i can help those in the MedDev space to stay compliant past the short-term focus on the EU MDR 2021 deadline.

Past the May deadline, i2i can assist the MedDev industry meet the relevant regulatory obligations by providing instant alerts when Standards and documents are updated. It can assist in the time-consuming process of maintaining reporting on regulatory requirements and increase efficiency and safety in the MedDev industry.

8 Benefits of Standards

8 Benefits of Standards

Compliance with Standards has a range of benefits

Standards can affect an organisation's quality, lead-time, supply chain management and costs. They make trade across international borders easier and promote global competition, having a positive impact on economies.

Understanding ISO 14971 2019

Understanding ISO 14971:2019

The medical device risk management Standard

The third edition of ISO 14971:2019 was published in December 2019 and provides a thorough process for manufacturers within the medical device industry to assess, monitor, and control risks in the creation and use of a medical device.

Health Care Technology

Health Care Technology

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Ultimately, health care technology focuses on improving services, products and treatments. Standards assist by setting industry best practice approaches, test methods, framework for management systems & strategies.

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