Challenges Faced by Medical Device Testing Laboratories

The medical device industry is complex and diverse, presenting unique challenges not only for manufacturers but also for the testing laboratories that support them. While much discussion focuses on the hurdles manufacturers encounter in bringing their products to market, the role of testing laboratories is equally critical and fraught with its own set of challenges.

Regulatory Landscape and Testing Requirements

Under the European Union’s Medical Device Regulation (EU MDR) 2017/745, manufacturers must demonstrate that their products meet the General Safety and Performance Requirements (GSPR). This entails comprehensive documentation and testing, covering everything from raw material sourcing to manufacturing processes, safety assessments, and efficacy evaluations for clinical use. Medical device testing laboratories are essential in this process, providing empirical evidence that devices are fit for their intended purposes.
However, the landscape for these laboratories is not without its challenges, which can be broadly categorised into four main areas:

Testing Standards
Accreditation and Certification
Acceptance of Data from Regulatory Submissions
Customer Understanding of Testing Requirements

1. Testing Standards

The vast range of medical devices necessitates tailored testing approaches, often focusing on usability, human factors, electrical safety, biocompatibility, and device-specific requirements. Numerous standards exist to guide testing, which adds complexity to the process. Many laboratories choose to specialise in specific types of testing – such as electrical safety under IEC 60601 – to manage the intricacies involved effectively. Interpreting these standards can be challenging, especially since regulatory requirements vary from country to country. For instance, a reusable surgical instrument must comply with different standards for cleaning validation depending on whether it is submitted to the EU or the FDA. While both might reference similar guidelines, the nuances in application can complicate compliance and testing processes.

2. Accreditations and Certifications

Accreditation is crucial for laboratories conducting medical device testing. Typically, ISO 17025 accreditation is the requirement, although biocompatibility testing often requires compliance with Good Laboratory Practice (GLP) standards. The acceptance of ISO 17025 by European authorities for certain in vitro tests contrasts with the FDA’s GLP requirements, illustrating another layer of complexity for laboratories navigating different regulatory environments.

3. Acceptance of Data From Regulatory Submissions

For test reports to be accepted by regulatory bodies, they must meet specific criteria, which can vary widely. Although medical devices must demonstrate safety and performance, different authorities may interpret data differently. Recognising which standards are accepted in various jurisdictions – such as the UK’s BSI adopting certain ISO standards as “BS ISO” – is critical for laboratories aiming to submit compliant reports. Test laboratories must possess deep knowledge of these standards and experience to navigate the regulatory landscape effectively. Clarity in how data will be processed by different authorities is essential to minimise the risk of push-back or rejection.

4. Customer Understanding of Testing Requirements

One of the most significant challenges is ensuring that customers comprehend the testing requirements for their products. Manufacturers often depend on laboratories for guidance in selecting and designing appropriate test methods. While laboratories provide impartial evaluations, they are also seen as experts and may be asked to offer consulting advice. This dual role creates a delicate balance; laboratories must help manufacturers choose the right tests while ensuring that their evaluations remain unbiased. The challenge lies in convincing manufacturers that the proposed testing approach will yield results accepted by regulatory bodies.

Medical device testing laboratories play a pivotal role in ensuring that devices meet safety and performance standards. However, they face numerous challenges related to testing standards, accreditation, data acceptance, and customer understanding. As the regulatory environment continues to evolve, laboratories must adapt and enhance their expertise to navigate these complexities effectively. Their success not only supports manufacturers in bringing safe, effective products to market but also ultimately protects patient safety and public health.

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Written by Enrico Allegra October 18th 2024

As a Clinical Microbiologist, Enrico has been working in the regulatory world of pre-clinical safety assessment for over a decade. He graduated with a Bachelor of Science degree in Immunology with medical Microbiology followed by a master’s degree in clinical microbiology Queen Mary University of London in 2013.

As part of his MSc’s project, he collaborated with the Barts Health NHS Trust to develop a diagnostic PCR cycle to detect Pneumocystis jirovecii in samples from immunocompromised patients. This helped reduce the turnaround time from several days to less than 12 hours.
During the height of the pandemic, he worked on the development of antiviral assays against Coronavirus as well as being part of clinical trial of bacteriophage technology to help fighting secondary infection of cystic fibrosis patients. Over the last few years, he has been actively involved the scientific community publishing various peer-reviewed papers for the introduction of novelty assays of safety assessments. He positively contributed pioneering new alternative to in vivo testing for cytotoxicity using insect models alongside cell culture testing. He is a certified biosafety officer acting as the Technical Lead at Test Labs for any UKAS ISO 17025 testing.

During his career he has worked as a Study Director conducting pre-clinical testing under GLP requirements working for a large CRO company. In this role he was able to gain expert knowledge for product testing to meet the requirements for regulatory submission to various authorising bodies, such as FDA, EPA, MHRA. He was heavily involved in method transfer and development, with a keen interest in bringing innovative testing procedures to meet client needs. As a result, Enrico used all his previous knowledge and expertise to help setting up the new Medical Device testing facility for Test Labs.

As part of his new role Enrico has helped the company achieving various new accreditations for Medical Device testing including the reprocessing validation for Class Ir Medical Devices under the scope of ISO 17025. Guiding the analytical team for reprocessing testing he has gained invaluable knowledge in customising testing regimes to accommodate reprocessing of reusable Medical Devices with emphasis on process optimisation and safety aspect.

Here at Test Labs, he acts as the Head of Laboratory overseeing the operation of Medical Device testing spanning from microbiology, chemistry and product testing. Guided by a deep understanding of product development and regulatory standards, he strives for excellence in both clinical evaluations and technical assessments.