EU MDR Vigilance Reporting Requirements and MEDDEV 2.12-1 Rev 8: What Has Changed?
First, it is important to note that on October 7, 2019, the European Commission published Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev. 8. This new guidance document identifies in Section 4 the updated Manufacturer’s Incident Report (MIR) form – MIR form V7.2. This form became mandatory in January 2020. This form is universally applicable for all Incident/Serious Incident reporting under the AIMDD, MDD, and IVD Directives and the new EU MDR and EU IVDR Regulations.
Important: Since the new EU MDR will become mandatory for all postmarket activities beginning May 26, 2021, medical device manufacturers need to ensure that their procedures are updated and employees responsible for vigilance reporting are trained on the change in reporting timeline.
What About MEDDEV 2.12-1 Rev 8?
MEDDEV 2.12-1 Rev 8 was published in January 2013 and provides guidance to medical device manufacturers on market surveillance. It continues to be the primary guidance document for vigilance reporting, even with the implementation of the new EU MDR and IVDR. However, Article 87 of the new EU MDR and Article 82 of the EU IVDR have shortened the timeline for vigilance reporting of serious incidents that did not lead to death or serious deterioration in health from 30 to 15 days. Because these regulations take precedence, it is anticipated that the guidance will soon be updated to be consistent with the new vigilance reporting requirements.
Here’s a comparison table of medical device vigilance reporting requirements.
To learn more about reporting requirements across the globe, read our article, Medical Device Incident and Adverse Event Reporting Timelines in 6 Major Markets.
Where Medical Device Incidents Must Be Reported, and Not…
Any serious incident that occurs with a device that is not in the EU market and did not lead to a Field Safety Corrective Action (FSCA) is still not reported through vigilance in the EU.
Section 5.1, paragraph 4 of MEDDEV 2.12-1 Rev 8 was written to support the MDD, AIMDD, and IVDD vigilance reporting requirements, and very clearly states the following:
“INCIDENTs which occurred outside the EEA, Switzerland and Turkey do not lead to a FIELD SAFETY CORRECTIVE ACTION relevant to these geographic areas do not need to be reported.” “Outside the EEA, Switzerland and Turkey” means any country that has not placed the device on the market under one of the directives, or more specifically (in the current regulation language) within the “Union Market.” In case you are wondering about Brexit, the UK is still operating under the EU device directives and will also in May operate under the MDR until the end of 2020. The UK may extend this deadline.
Subsequent to that guidance, the EU MDR and IVDR were released, and there has been widespread confusion around the new language in paragraph 1a of Article 87 of the EU MDR (Article 82 in IVDR) for reporting of serious incidents, which states:
“… any serious incident involving devices made available on the Union market…”
It could be interpreted (that would mean) that if a certain model of device has been distributed in the EU market and an event occurs outside of the EU market, then since that same model of device is “available on the EU market” it would now need to be reported.
However, look at the wording in paragraph 1b of MDR Article 87 (Article 82 in IVDR) for reporting, which 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.”
It becomes clear from the statement in paragraph 1b that the same reporting requirements remain in effect as per the MEDDEV 2.12.1 guidance. Specifically, that reporting is only required for serious incidents occurring for events where the device is actually in the EU market, unless an event occurring outside the EU leads to an FSCA affecting devices in the EU.
If you still think the new language in paragraph 1a requires you to report vigilance for serious incidents that occur with devices outside of the EU market, to which Competent Authority would you report the incident? The reporting of incidents under the new regulations is based on future use of an electronic system (EUDAMED). Note that Article 92, Section 5 of the MDR states:
“The reports on serious incidents referred to in point (a) of Article 87(1) shall be automatically transmitted, upon receipt, via the electronic system referred to in paragraph 1 of this Article, to the competent authority of the Member State in which the incident occurred.”
There clearly is no relevant “Member State” competent authority for serious incidents that occur outside of the EU market.
Want to Learn More?
With the EU MDR implementation fast approaching, you need to stay updated on its impact on your company. Consider our EU MDR auditing class, our IVDR transition class, or this focused training course on medical device complaint management and vigilance.