EU provides guidelines for high-risk IVDs as well as surveillance of older medical devices

IVDR specifies specific specifications that apply to Class D IVDs, a classification that includes diagnostics used in areas at risk for public health and the patient. The notified bodies must verify the batch of class D IVDs. This means that manufacturers must forward batches of test results and access their products. The body notified must request to use an EU Reference Laboratory (EURL) to test batches.

The MDCG guideline outlines the role that notified bodies play in the process and gives the best methods. For example, notified bodies must have documented procedures for verification and developing a test program and agreements with manufacturers regarding what and when batch testing takes place.

MDCG expects notified bodies to prepare a test plan for every class D IVD and provide it to the EURL. The plan must reflect the outcomes of the conformity assessment conducted by the notified body and the performance verification report of a EURL or any other relevant information. The guidance allows EURL to EURL to "propose justifiable changes based on its knowledge of science."

Useful Resources – 

• IVDR CE Marking
• IVDR Performance Evaluation Report
• CLASSIFICATION OF MEDICAL AND INVITRO DIAGNOSTIC DEVICES

The other sections in the guidelines provide details on the contract between the notified body and the manufacturer. The guidance suggests that the agreement should contain the EURL-approved test plans and details regarding the logistics of sharing samples and the supply information on batch releases, quality assurance outcomes from manufacturers, and more.

MDCG issued the IVDR guideline the day before publishing a document on monitoring devices that were launched under the old directives on devices. Transitional arrangements allow devices that have valid certificates issued under the directives to remain in the marketplace despite being subject to the Medical Device Regulation now applying.

The guidance states that "in principle that the quality management system endorsed by the directives must maintain." However, this directive Medical Device Regulation (MDR) provides new requirements regarding the post-market surveillance system, markets surveillance, and economic operator registration applicable to older devices.

In light of this fact, MDCG is asking notified authorities to confirm whether the manufacturers have modified the quality control systems according to the guidelines on significant changes and if they've established procedures for post-market monitoring and other areas where MDR complies with the regulations. When the documentation review is completed, the notified body must make use of the findings to help update the audit plan.

MDCG's most recent guidelines continue the flow of information on IVDR and MDR. This week, The European Commission released an update to the joint implementation strategy for IVDR, reflecting the transition towards a gradual introduction of the rules.

Despite IVDR's recent extension certification times beyond the date of formal application in May 2022, there is still a lack of organizations that are notified in the European regulatory environment to begin the first year of full calendar in the year of MDR along with the introduction of IVDR.

"Before IVDR and its new idea of classifications, only 20% of IVDs were required to undergo an assessment of conformity with an approved body. However, as many as 80% will require an assessment from a notified body," according to the health data science firm IQVIA. "Even if the shortage of notified bodies is beginning to decrease in the second half of 2022, the clinical (performance evaluation) demands and post-market regulations pose significant issues for both MedTech as well as IVD makers."

Article source: https://article-realm.com/article/Finance/19657-EU-provides-guidelines-for-high-risk-IVDs-as-well-as-surveillance-of-older-medical-devices.html