WHAT IS ISO 14644 CLEANROOM ENVIRONMENTS FOR MEDICAL DEVICES?
The regulatory review and approval process for medical devices in the European Union (EU), the U.S. and many other jurisdictions requires manufacturers to provide evidence that their production and manufacturing facilities are designed and operated to ensure that finished products consistently meet the manufacturer’s specifications. The integrity of the manufacturing process is especially important for any medical device that comes in direct or indirect contact with a patient, since they can be easily contaminated with microbiological or chemical residues produced within the manufacturing and distribution environment.
Cleanrooms are ideally suited for the manufacturer of these types of medical devices. Cleanrooms are enclosed and environmentally-controlled spaces in which temperature, humidity, pressure and contaminant levels are kept within strict limits. The controlled environment provided by a clean room helps to ensure that products remain under controlled contamination levels throughout the production process, thereby reducing potential risks to patients. Therefore, appropriate cleanroom designs, and the implementation of personnel policies and procedures that control work within the cleanroom environment, are critical for the production of safe devices.
REGULATORY LANDSCAPE FOR DRUG/DEVICE PRODUCTS
Despite the clinical advantages offered by combination products in treating certain medical conditions, the regulatory review and approval process for combination products is generally more complex than that applicable to non-combination products. In the European Union (EU), for example, the evaluation by a Notified Body of medical devices incorporating medicinal substances must include an opinion of a competent authority designated by an EU Member State, a process that can take more than 210 days (210 days + clocks stops) to complete. In the U.S., the Food and Drug Administration (FDA) handles the pre-market review of combination products through its Office of Combination Products (OCP), which then determines the appropriate process based on a review of the device’s primary mode of action (PMA). However, this determination alone can take up to two months before the actual pre-market review commences.
Manufacturers of combination products are encouraged to develop a detailed regulatory strategy as early as possible in the development process for new combination products. An effective regulatory strategy can provide a detailed plan and schedule for the regulatory approval process that is consistent with the manufacturer’s plans for market introduction. Combination product manufacturers should also seek advice from regulators, authorities and competent third-parties regarding the documentation required to support CE mark approval applications, including clinical evaluation reports, drug file (CTD-Format) and technical documentation. These steps serve to make the approval process as efficient as possible, and can help reduce the risk of unexpected challenges and setbacks that can prolong or jeopardise product approval.
TÜV SÜD MALAYSIA SERVICES
- Product safety testing and certification - TÜV SÜD Product Service is an EU Notified Body for medical devices, and is recognised by other regulatory agencies throughout the world for its extensive experience with a broad range of medical devices.
- Risk management expertise - TÜV SÜD experts have extensive experience in every aspect of risk management systems for medical device manufacturers in accordance with ISO 14971, and conduct thousands of in-depth risk management audits each year.
- FDA 510(k) third party review service - TÜV SÜD Product Service has participated in the FDA 510(k) third-party review program since its inception in 1996, and offers third-party submission reviews for over 600 devices. TÜV SÜD Product Service medical device experts maintain close contact with FDA reviewers to ensure that issues are promptly addressed, resulting in a more efficient review process and timely product clearance.
- Other testing and certification services - In addition to expertise in drug/device combination products, TÜV SÜD Product Service can pre-assess the compliance of devices with other relevant regulations and standards such as ATMP/Medical device combination sterilisation and risk analysis requirements.