Human beings become considerate when it comes to their own lives and do everything possible to live their lives peacefully, without any problems, especially medical problems. But when things go off the track, they try every possible thing to keep their health steady and for that they use many medical devices.
Several medical devices companies around the world are busy in manufacturing medical devices and their production requires great care. But sometimes, mistakes happen which can be very lethal for the patients or for the users. To ensure that a medical device is safe for human use, many measure are taken and vigilance reporting is one of them.
What is Vigilance Reporting?
Vigilance reporting is a type of reporting which covers causes and reasons of different incidents involving products of an organization. It includes those safety measures which are taken to minimize the cause of any incident or reduce the impact of any incident on the user of a certain medical device or a product.
This blog will cover different guidelines provided by new MDR and IVDR regarding vigilance reporting. The new guidelines were supposed to be implemented from May 2020, but the recent COVID-19 pandemic has postponed its implementation till next year.
EU MDR and Their Guidelines Regarding Vigilance Reporting
EU has recently made some changes regarding report of any incident which happens within an organization that can risk the life of its workers. Any medical device manufacturer is strictly required to report any adverse incident that happens and any corrective measures otherwise known as Field Safety Corrective Options (FSCAs) to EU’s Competent Authorities.
What Are Vigilance Reports?
Vigilance Reports cover Incident Reports (IR) and Field Safety Corrective Actions (FSCA) reports. According to Additional Guidance regarding Vigilance System in MEDDEV 2 12-1 Revision 8’s section 4, the manufacturer is required to file a Manufacturer’s Incident Report (MIR). This MIR form was updated on 30th September, 2019 and contains the updated version of MIR. This form became mandatory from January 2020 and covers incident reports from all the serious incidents under AIMDD (Active Implantable Medical Device Directive), MDD (Medical Device Directive), IVDD (In-Vitro Device Directive) and the newly published EU MDR (European Union Medical Device Regulations) and EU IVDR (European Union In-Vitro Device Regulations).
When Are Vigilance Reports Required?
A vigilance report is required when any adverse incident happens or any corrective action (also known as Field Safety Corrective Action – FSCA) is taken to reduce the happening of any such incident. Article 87 of the new EU MDR and Article 83 of new EU IVDD have reduced the time period of reporting vigilance reports for incidents which can cause serious health risk from 30 to 15 days.
Guidelines in EU MDR, IVDR and MEDDEV 2 12-1 Rev 8
MEDDEV 2.12-1 Rev 8 was published in January 2013. It serves as the primary document for medical device manufacturers on market surveillance and vigilance reporting. It is assumed that even after the implementation of new EU MDR and EU IVDR, the MEDDEV 2.12 Rev 8 will continue to serve as the basic reporting document in terms of market surveillance.
Adverse Incidents and FSCA Reporting Process
Following are the basic steps for reporting of any adverse incident or FSCA process:
- MEDDEV 2.12/1 will be taken a reference for reporting of any adverse incident
- Competent Authorities shall be informed about the severity of incident.
- Give appropriate response to the Competent Authorities regarding their questions about devices involved, their market status and changes in design.
- It is responsibility of the manufacturer to determine if Field Safety Corrective Actions (FSCA) and Field Safety Notice (FSN) are necessary and if they are, then they must be reported to Competent Authorities.
- Final submission of FSCA report to Competent Authorities.
- Addition of vigilance reports along with correspondence to the CA, ISO 13485 or any other quality systems.
- Unless your device is Class-1 certified, report your Notified Body regarding any incidents or FSCAs.
Any serious incident that happens with the device which is outside of EU market and did not lead to FSCA is not reported through vigilance in EU. This can be made clear by Section 5.1, paragraph 4 of MEDDEV 2.12/1 Rev 8 which states
“Incidents which occur outside the EEA (European Economic Area), Switzerland and Turkey do not led to a FSCA relevant to these geographic areas and do not need to be reported.”MEDDEV 2.12/1 Revision 8
The statement “Outside EEA, Switzerland and Turkey” refers to any country whose manufacturer has not placed their device under any one of the directives within the Union Market. As for the United Kingdom, it is still operating under EU device directives (even after the Brexit). Moreover, it was supposed to start operating under new MDR from May 2020 up till the end of 2020, but due to recent CoVID-19 outbreak, implementation of new MDR has been postponed till May 2021 and hence, UK might consider making changes in its decision.
It will be worth noticing a change in the language in article 82 of IVDR. This paragraph is for reporting of serious incidents. It states
“Any serious incident involving device made available on the Union Market…”EU IVDR
It could be interpreted as an incident that occurs with a device outside the EU market and that device is also placed within the EU market. Now if any incident that occurs with that device outside the EU market is needed to be reported.
Similarly, the paragraph 1b of MDR article 87 (Article 82 of IVDR) states
“…any field safety corrective action in respect of devices made available on the Union market, including any field safety corrective action undertaken in a third country in relation to a device which is also legally made available on the Union market, if the reason for the field safety corrective action is not limited to the device made available in the third country.”EU MDR
It becomes clear from the statement of this paragraph that reporting is required only for the serious incidents that happen inside the EU until and unless an event occurs which lead to an FSCA affecting the devices in EU. Also, the reports of any incidents occurring shall be reported via electronic system of EUDAMED to the Competent Authority of the Member State in which incident has occurred.
TS Q & E can help companies to streamline their processes for medical device vigilance reporting both for devices related to the MDR and IVDR. Inquire us through our Contact us page.