Medical device regulations is continuously evolving across the globe. A medical device technical file is a mandatory document that needs to be submitted by the medical device company to the regional regulatory authority where the device is to be sold. As the number of submissions and approvals rises every year, keeping up with these transitions becomes essential. Additionally, every device is unique and has its own sets of regulatory requirements in terms of documentation which makes e-submissions challenging. Device technical file publishing shows the regulating body that the medical device complies with the relevant authoritative regulatory standards.
As the regulatory transitions become eminent, more focus is placed on the accuracy with which the guidelines are established by the agencies across the globe alongside setting up templates and requirements. From the manufacturer’s perspective, MDR technical file becomes critical, as it has to fulfil the requirements of the General Safety and Performance Requirements (GSPR) and have to be structured as per the Health Authority requirements. Device Technical File Publishing has to be planned from the initial process of device development. This process should also include transfer and retention of the technical files for a period of 10 years from the period the device is placed in the market. It must be retained with the authorized representative or manufacturer as an electronic or hard copy.
These submissions are essential when devices of different classes are manufactured by the same company. Regulatory agencies like, the US FDA and EU have already established the submission requirements for eCopy generation and submission of the device technical files for below submission types, among which for some it is mandatory, while for other submissions it is voluntary.
- 510(k) submissions, including Third Party 510(k) submission
- De NovoSubmissions
- PMAs, including Transitional PMAs
- CE marking
- INDs (Combination products)
- BLAs and associated amendments (Combination products)
- CLIA submissions (CRs and CWs)
- 513(g) submission
- At Freyr we are aimed at providing an expert review to ensure all the essential requirements of technical file for medical device are met
- Creation of the e-Copy/electronic folder structure
- Creation of the regional documents and tagging of files
- Insertion of all appropriate document and submission documents along with bookmarking and external hyperlinking followed by compilation, publishing, and validation
- Performing Document Level Publishing (DLP) including bookmarking, internal hyperlinking, word to PDF conversion, scanned document to readable format and make them submission ready documents for e-Copy publishing
- Performing required quality checks as per country specific Regulatory standards before submissions
- Finishing activities include those activities associated with the creation of region/ country specific application versions and may include creation of electronic submission, burning CDs and binding
- Structured solutions and support for e-copy preparation and submission of technical files
- Support for all risk class devices and required submission types
- Continuous support to the product, throughout its Lifecycle
- Delivery mechanisms to provide Regulatory submissions to local Regulatory subsidiaries, agencies worldwide, and internal customers