What should medical device manufacturers prepare to follow the changed regulations?

According to the requirements of Article 10, general obligations of manufacturers from Regulation (EU) 2017/746, medical device manufacturers should establish, document, and implement a quality management system. To follow the IVDR requirements, manufacturers should evaluate the effects on the quality management system and record the management history. Additionally, manufacturers shall document the process of the UDI system and the labeling. According to article 15 of Regulation (EU) 2017/746, there is a Person Responsible for Regulatory Compliance (PRRC). Within manufacturing companies, at least one person possesses the requisite expertise in the field of in vitro diagnostic medical devices. The qualification and rules of this position should be documented. [1]

Medical devices should achieve the performance requirement when designed and manufactured and they should permit the standard for the intended purpose. In order to demonstrate this, the manufacturer shall prepare technical documentation, including the characteristics and performance of the device according to the requirements of Annex II of IVDR. A key part of the Technical Document is the Analytical and Clinical evaluation report, the output of the design verification and validation phase. 

Technical documentation on post-market surveillance is addressed in Annex III of IVDR. According to the Annex III, Manufacturers should prepare the PMS plan, PMS report, PSUR(Periodic Safety Update Report), PMPF (Post-Market Performance Follow-up) depending on device class. Furthermore, manufacturers should revise the PMS process for the IVDR regulations. Depending on the risk class of the medical device, manufacturers should confirm the quality/performance/stability of the medical device during its whole life cycle and build up to the PMS process to evaluate the risk management process. The revision of the PMS process is required to assess the technical documentation file, risk management process and documents, and design and development document. [1]

When the confidential information of European patients is provided to the manufacturers, articles related to protection shall be added to the requirements for manufacturers. Medical device manufacturers should build a process according to the GDPR (EC) 45/2001 based on the IVDR confidentiality and data protection articles. The minimum document preservation period was adjusted to 10 years. The start date of this period is the market launching date of the device. [1]

Finally, manufacturers who prepare the IVDR audit should arrange an internal audit to avoid nonconformity. Before the IVDR audit, all departments of the manufacturer should add the IVDR requirements to their internal audit checklist and confirm whether they are suitable for the regulatory requirements. [1]

What GENECAST is preparing

GENECAST is constantly monitoring the latest trends in IVDR to receive IVDR certification by 2024 and is preparing to improve employees' understanding of regulations through training. We also preparing to establish a QMS that complies with IVDR and update technical documents.

Specifically, we are updating QMS. We already revised Quality manual, Design and Development Management procedure, Risk Management procedure, and Feedback and PMS procedure etc. We are currently working on revising performance evaluation procedure.

Also, we started to write technical documentation file according to IVDR 2017/746 Annex II. Device description, labeling, design and manufacturing information, General Safety and Performance Requirements (GSPR), Benefit-Risk Analysis and Risk Management, Product verification and validation, PMS(Post Market Surveillance) Plan and PSUR(per Class C)Report, and DoC(Declaration of Conformity) are prepared in accordance with the requirements of IVDR 2017/746 Annex II and Annex III. Analytical Performance Evaluation and Clinical Performance Evaluation of ADPS EGFR Mutation Test Kit, is in Progress. In addition to this performance evaluation, we have revised and completed General Safety and Performance Requirements (GSPR) Checklists, DoC, PMS(Post-market Surveillance)Plans and PSUR, PMPF report form and Risk Management Report (including Benefit-Risk analysis). 

It takes more process to receive IVDR certification, but GENECAST is working hard to sell its main product which is ADPS EGFR Mutation Test kit v1 and ADPS BRAF Mutation Test kit v1 to EU countries without a hitch.

Reference

[1] Regulation (EU) 2017/746 on in vitro diagnostic medical devices