The globalisation of the medical device industry has created both opportunities and challenges for manufacturers. Running parallel to this expansion is a greater dialogue on harmonisation efforts throughout the EU and other major medical device markets. The current revision of ISO standard 10993-1 may present challenges for medical device companies seeking to adhere to the principles and regulatory requirements for the biocompatibility testing for medical devices.

ISO 10993 was developed, in part, parallel to the evolution and growth of the medical device industry. As devices, especially implantable devices, became more advanced and widespread, it became necessary to develop standards that could test toxicity levels of materials that had significant and prolonged exposure to the human body. In 1986, regulatory authorities in Canada, the UK and the US developed and issued the Tripartite document.

The document provided guidance on choosing and selecting tests to be used in toxicity testing and was heavily relied upon in its first decade of its inception. However, as the industry became more globalised, the Tripartite document would be eventually replaced by ISO 10993-1. This was a further step by regulatory authorities to ensure the safety and efficacy of medical devices for human use.

Ensuring the safety and efficacy of devices for use is becoming an increasingly public issue. In the wake of several high-profile safety incidents, many manufacturers are taking additional steps to ensure that their products are both safe and effective for their intended uses.

While individual manufacturers are taking additional steps, regulatory agencies and lawmakers are reviewing whether or not extra controls are needed in order to ensure further compliance to set standards and regulations or even if new requirements are necessary.

In the US, for instance, Congress is considering legislation that seeks to add regulatory scrutiny to device companies manufacturing in foreign facilities. The measure, the Food and Drug Globalization Act of 2008, would increase the number of inspections conducted by the US FDA in order to further ensure the safety of products entering into interstate commerce in the US.

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The potential legislative and regulatory changes in the US are only one example of efforts to ensure the safety and effectiveness of medical devices from a macro level. Individual companies face challenges in testing the biocompatibility of their products in accordance with ISO standards as well as EU, FDA and other foreign-national guidance. Adhering to practical guidelines within biocompatibility testing processes will be critical in dealing with appending changes within testing standards in IS0 10993-1.

Moreover, taking broad, high-level action will ensure that a medical device company will be able to deal with the changing tides.

Develop a strong regulatory team

Evaluating a medical device biologically is a critical process in a variety of respects. Testing a device biologically depends on several measures, including the duration that the device is in contact with a body tissue, the intended type of body contact and the material which is used within the specific device. Devices which have greater contact with areas of the body, such as implantable devices, run a greater risk of presenting some sort of misalignment in biological compatibility.

In light of potential changes to existing ISO policy, it is important to have a regulatory team in place in order to assure full compliance with any changes in standards. Your regulatory team should gain expertise on current, existing and potentially new revisions of testing standards.

This expertise can be achieved by having your team attend continuous professional development courses and training throughout the calendar year. In addition, many manufacturers have benefited from having a delegated individual responsible for team reporting of significant or substantial changes to regulatory policies. As TC-194 continues its work on 10993-1, such a designee would likely prove invaluable.

Regulatory team strength is only one critical aspect in adapting to impending regulatory change. If testing standards are substantially modified, it is possible that internal company protocols will potentially be affected. Changing the way business is conducted is never an easy task and will create considerable challenges in corporate culture over the long term. However, developing a regulatory team that is ahead of the curve will prove invaluable.

Relationships with regulators

ISO 10993-1 was established as part of an effort to bring greater harmonisation to the ever-growing international medical device industry. Complying with varying sets of regulatory requirements may prove burdensome to companies, especially those in highly regulated markets.

Establishing a productive and positive relationship with the appropriate regulatory authorities will prove useful in the product development phase of new and innovative medical devices.

“With a greater number of devices being implanted, the level of risk created by exposing patients to materials also increases.”

The European Commission and FDA, as well as other agencies, will actively work with manufacturers in the development of a new product. This relationship will usually provide the necessary guidance required in order to form the tests required for regulatory submission.

Toxicity tests, in general, can involve a complicated set of evidence-based standards. Some of the tests that may be used to assess the toxicity of a specific substance include acute systemic toxicity, hemocompatibility, chronic toxicity, carcinogenicity and skin sensitisation, among others. Within each test are different disciplines of knowledge. The appropriate regulatory authorities will have specific subject matter experts to deal with this variation, as well as any forthcoming requirements.

The FDA Center for Devices and Radiological Health, for example, has numerous personnel who work with companies in the submissions of their premarket approval applications and, to some degree, 510(k) applications when testing for the toxicity levels of certain materials.

It is important for many new medical device manufacturers to realise that regulatory agencies will, in many ways, provide more help to the development of a product rather than provide a hindrance. In light of the forthcoming challenges that may be presented by the current revision of 10933-1, it is important for medical technology companies to recognise the inherent advantages of regulatory agencies.

Working with trade associations

At a micro level, there is no substitute for a well-informed, expert-laden regulatory team within your company. While ISO standards changes can move at glacial speed, other avenues are available in order to ensure that compliance standards are being met. Moreover, it is important for manufacturers to be aware of the potential business impact that legislative and regulatory changes will have on a company’s portfolio and ledger.

With likely changes in 10993-1, a maze of confusion will potentially be created as internal regulatory offices of medical device companies scramble to understand and analyse changes that will impact the business. Trade associations can often offer some relief in the challenges companies face of achieving an understanding of forthcoming and current regulations.

Associations often will host timely workshops, seminars or summits which will provide guidance on current ISO standards universally or on specific regulations for the specific countries of origin. These events often provide invaluable insight and guidance with respect to broad regulatory changes. Moreover, they serve as opportunities for medical device manufacturers to interact with regulators and other stakeholders.

In times of broad regulatory change, trade associations are an ideal and vital resource. In addition to continuous educational seminars for regulatory managers, associations develop products such as white papers and other guidance to provide insight to their membership.

With the upcoming changes within ISO 10993-1, there will undoubtedly be a wealth of questions generated from regulatory and compliance managers. Connecting these personnel with the appropriate associations will minimise confusion and equip staff with the appropriate and necessary knowledge base in conducting toxicology tests.

“Developing a strong regulatory team is a crucial step in adhering to the potential forthcoming changes.”

Essential regulation

The medical device market is a growing and dynamic marketplace faced with continuing and increasing regulations. In the relatively short life span of ISO 10993, significant changes have presented various challenges to medical technology companies.

With a greater number of devices being implanted, the level of risk created by exposing patients to materials also increases. With this increase comes a greater necessity for toxicology tests to ensure that the materials used in devices are also safe and effective for patient use. The outcomes of any revision to the current standards will likely include a maze of confusion and more questions about processes rather than answers.

Developing a strong regulatory team is a crucial step in adhering to the potential forthcoming changes. Your regulatory team should have a strong and demonstrable understanding of what additional tests may be required for determining toxicity, what additional categories may be created within ISO 10993-1 matrixes and other crucial aspects of the process.

Regulatory teams should understand that most government agencies are willing to provide an adequate level of guidance in complying with standards. It will be to their benefit, as well as a company’s, to make the most of these relationships. In addition, trade associations often offer invaluable insight into the regulatory process.

While these recommendations are by no means exhaustive, they will hopefully provide a macro-level overview of some of the proactive steps companies can take in order to achieve compliance with potential changes to ISO 10993-1 and minimise the impact on a company.