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Regulatory Compliance For Medical Device Component Manufacturers

Medical Devices have many forms of part or component inputs.

1. There are components which are assembled to make a device. Each component, though not a device by itself has an important, if not a critical role to play. The components are used in the device as such or sometimes treated.

So we can realize the importance of maintaining their quality. In today’s world of GMP, GLP, GDP it becomes critical that their manufacturers follow basic good manufacturing practice, test them using good laboratory practices and even transport or distribute them taking care that they are not damaged during transit, so good distribution practices.

2. There are components supplied as sub assembly. This means some of the components are assembled at the premises of their supplier to form a particular part of a medical device as an integral part. They need to follow same fundamental care because again most of these subassemblies are put together without much treatment or process of full cleaning and quality.

3. Sometimes medical devices are bulk supplied as non-sterile components. They are finally sterilized and packed at the manufacturer and supplier of medical devices.

From few of the above examples and comparison to medicines it becomes very clear that performance, safety and criticality of use (usability) of medical device is largely dependent on components and in most of the cases of manufacturer there are multiple part suppliers. These parts are assembled and if need be sterilized at the final manufacturer.

Thus consistency of the product quality and performance is dependent on component manufacturers as much as final device manufacturers.

Thus like API manufacturers are part of regulated industry there should be basic and minimum compliance responsibility and regulations should be for the component manufacturers.

Let us examine what it can be. As described earlier GMP and GLP as well as GDP becomes core of the regulatory need. What does it mean and what are the standards that can control them?

International standardization on Quality Management System has published ISO 13485 standard and the same is adopted by international community like US FDA under their 21CFR, European Union and MDSAP as EN ISO 13485. India was late to regulate medical devices and still made a beginning. We have taken as usual a very thoughtful and planned route, though belated, with minimum System requirements based on ISO 13485.

The supplier qualification and if required audit has been now widely recommended, even insisted upon. Especially if component supplier is not following audited QMS they need to be audited and approved by the final manufacturer of medical devices.

Thus supplier evaluation, qualification and approval have to be an integral part of the manufacturer’s QMS. Again like GMP in pharmaceutical industry; it is not a onetime exercise but should be followed at a planned interval. The requirements also should be clearly stated in the agreement between component manufacturer/supplier and final device manufacturer. Any changes in the specifications, composition of the component/part should need a prior approval. Major or minor non-compliance of the System need to be addressed and communicated / reported to the manufacturer of the device in a time bound manner. Traceability from raw material used to the component manufactured is required. Thus a system is required with documentation and records.

What is the title of ISO 13485 and where does it specify need to control components?

ISO 13485:2016 - Medical devices - Quality management systems - Requirements for regulatory purposes What does introduction of this standard says about its application to:

“The requirements in this International Standard can also be used by suppliers or other external parties providing product (e.g. raw materials, components, subassemblies, medical devices, sterilization services, calibration services, distribution services.”

Further it states that - “Several jurisdictions have regulatory requirements for the application of quality management systems by organizations with a variety of roles in the supply chain for medical devices.”

Though these are non-binding guidelines flowing clauses of the standard are more specific:

Clause 7.4.1 from the standard I quoted here. Its requirements can be expanded subsequently. Underlined information is from the author of this article.

7.4.1 Purchasing process: The organization shall document procedures (see 4.2.4) to ensure that purchased product conforms to specified purchasing information. The organization shall establish criteria for the evaluation and selection of suppliers. The criteria shall be: a) based on the supplier’s ability to provide product that meets the organization’s requirements; b) based on the performance of the supplier; c) based on the effect of the purchased product on the quality of the medical device; d) proportionate to the risk associated with the medical device. The organization shall plan the monitoring and re-evaluation of suppliers. Supplier performance in meeting requirements for the purchased product shall be monitored. The results of the monitoring shall provide an input into the supplier re-evaluation process. Non-fulfillment of purchasing requirements shall be addressed with the supplier proportionate to the risk associated with the purchased product and compliance with applicable regulatory requirements.”

The product standard compliances are a different but critical aspect and at least risk based approach and biocompatibility requirements as per ISO 10993-1 should be adhered to by the component manufacturer.

Conclusion: From above points, a broad requirement emerges which becomes specific based on the criticality and risk of the device.

It is in the interest of component manufacturer, device manufacturer and above all user patients, that risk based regulations using Quality Management System (QMS) principles are a must for all aspects of medical device manufacturing including component manufacturers/suppliers. Why all these discussions now? See the increase in the use of and expansion of the medical device industry. The global medical device market is predicted to reach $440 billion as per 1988 predictions, growing at a rate of about 4.4 per cent per year. Compare this with the anticipated growth of the prescription drug market – an annual rate of 2.5 per cent.