The new form Manufacturer Investigation form for reportable events in EU is mandatory starting this…
What can go wrong? Double the work and half the time for mandatory reporting
A likely cause of a nonconformance (NC) before and after IVDR or MDR accreditation is associated with tighter Vigilance reporting requirements.
What changed? EU2017 746 IVDR Article 82 (2) / EU2017 745 MDR Article 87 (3)
“Manufacturers shall report any serious incident* immediately after they have established the causal relationship between that incident and their device or that such causal relationship is reasonably possible and not later than 15 days after they become aware of the incident.”
| Event Type | Initial Reporting Timeline |
| Serious public health threat | a serious public health threat must be reported immediately, and not later than 2 days after the manufacturer becomes aware of that threat (Article 87(4) MDR/Article 82(4) IVDR), |
| Death or UNANTICIPATED serious deterioration in state of health: | death or an unanticipated serious deterioration in a person’s state of health must be reported immediately and no later than 10 days after the awareness date of the serious incident (Article 87(5) MDR/Article 82(5) IVDR). |
| Serious incidents | any serious incident that did not involve a death or an unanticipated serious deterioration in a person’s state of health must be reported immediately, and no later than 15 days after the awareness date of the serious incident (Article 87(3) MDR/Article 82(3) IVDR), |
Increasing Post Market Surveillance Compliance Complexity
Different reporting methods depending on the origination of the complaint, and daisy chain of communication through the supply chain can make compliance to mandatory reporting timelines very difficult to meet consistently.
Foreign country notification requirements and the closed loop post market surveillance requirements increases complexity between annual reporting , risk analysis, and investigation.
- The foreign country notification requirement is analogous to the US medical device reporting requirements which requires Vigilance reporting of field safety corrective actions that may impact product marketed in the EU even though the field safety corrective action is not taking place in EU. (See Compliance & Vigilance Analysis/Evaluation – Ph1- MDR – QMS Velocity)
- Closed loop post market surveillance requirements includes updating Risk Management to ISO14971: 2019 requirements and add the post market annual reports for products. (See MDR Phase 1 – QMS Velocity)
In short, the new regulations and laws require existing process to be more complex while simultaneously reducing the time to perform a lot more work.
The key to get through this as quickly as possible are the following:
- Make risk management updates as efficient as possible (using excel and formula to automate data entry – for example: Risk Management Workbook-MDR – QMS Velocity)
- Train importers and distributors on reporting responsibilities (Training, Distributors and Importer Responsibilities – QMS Velocity)
- Implement a closed loop post market surveillance system first (See MDR Phase 1 – QMS Velocity) and then focus on other quality system updates. Updating the QMS and Post Market Surveillance system is likely supported by the same resources. The PMS updates require immediate compliance and evidence of compliance will be audited as part of meeting IVDR/MDR transitional requirements.
Helpful Links:
Closed loop post Market Surveillance – Webinar
Webinar Slides – Closed Loop Post Market Surveillance
*Note the following serious incidents are excluded from this requirement:
- For medical devices, this requirements excludes incidents related to expected side-effects that are included in trend reporting.
- For Invitro Diagnostic devices, this requirement excludes expected erroneous results which are clearly documented and quantified in the product information and in the technical documentation
\:
K. Seiki
Related Posts
