Certify your cleanroom manufacturing environment with ISO 14644
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.
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.
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