Newsletter No 31 Februry 2023

Subject: Incident definition, Vigilance and dealers’ obligations

The Regulation 2017/745 (MDR) has further developed, among other topics, the management of the vigilance system and vigilance reporting. In this newsletter, we will take a closer look at some vigilance terms and concepts that are outlined in MDR chapter VII, section II, and in the newly published guidance MDCG 2023-3.

What is an incident and a serious incident?

An incident is, according to Article 2 (64) MDR, any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side effect.

A serious incident is, according to Article 2 (65) MDR, any incident that has directly or indirectly led, might have led, or might lead to any of the following:

• The death of a patient, user, or other person.
• The temporary or permanent serious deterioration of a patient’s, user’s or other person’s state of health.
• A serious public health threat.

Therefore, the main difference is the severity of the related health or public health outcome or potential outcome linked to an issue with a device made available on the market.

Which incidents are reportable and how are they reported?

Serious incidents are reportable as Manufacturer Incident Reports (MIR) according to Article 87 MDR. The expected side-effects which are clearly documented in the product information and quantified in the technical documentation are exempted from MIR reporting and are subject to trend reporting.

Conversely, incidents that do not meet the definition of serious incidents are not reportable as incidents but must be documented and considered in the manufacturer’s Quality Management System, assessed to detect trends, and reported as Manufacturer Trend Reports in case of significant increase in their frequency or severity according to Article 88 MDR Trend reporting.

If, after becoming aware of a potentially reportable incident, the manufacturer is uncertain about whether the incident is reportable, it must nevertheless report within the timeframe established.

The timelines for incident reporting are the following:

• Serious public health threat: must be reported immediately after the manufacturer becomes aware of the threat and no later than 2 calendar days from aware date.
• Death or an unanticipated serious deterioration in a person’s state of health: must be reported immediately after established/suspected causal relationship between the device and serious incident and no later than 10 calendar days.
• Any other serious incident: must be reported immediately after causal relationship is established/causal relationship is reasonably possible between the device and serious incident and no later than 15 calendar days.

To ensure timely reporting, the manufacturer can submit an initial MIR which can be followed by a follow-up MIR. Once the manufacturer completes the investigation, they submit the final MIR. If as a result of the root cause investigation or awareness of other new data the manufacturer determines that the event is no longer a reportable incident, the final MIR is submitted as not reportable.

Reportable incidents and trends must be reported to the Competent Authorities (CA) of the member state(s) in which the incidents occurred and, where applicable, to the Notified Body (NB) that issued a certificate for the device.

The manufacturer may agree an alternative reporting regime named Periodic Summary Reports (PSR) with the respective national competent authority that is coordinating the periodic summary reporting (and in consultation with the competent authorities referred to in Article 92(8)(a). The aim is to report similar serious incidents with the same device or device type in a consolidated way, for cases such as identified root cause, FSCA implemented or common and well-documented serious incidents.

What are the sources of the vigilance information?

The manufacturer receives vigilance information:

• From a healthcare professional, patient or user about a suspected incident related to a device
• Via a competent authority
• From an economic operator, for example a distributor
• During its own routine monitoring activities, for example its post-market surveillance, post-market clinical follow-up (possible sources: literature searches, registry data, questionnaires, etc)

Analysis of serious incidents and field safety corrective actions

The complaint and trending process, in addition to the reportability decision and investigation, typically include escalation determination for corrective and preventive action (CAPA) and field safety corrective action (FSCA). In the case of the serious incidents reported, the competent authority conduct an investigation including risk assessment for which may need documents from the manufacturer.

As a result of the investigations, a FSCA may be initiated by the manufacturer or requested by an NCA.

What is a field safety corrective action?

A field safety corrective action (FSCA) according to Article 2(68) MDR is a corrective action taken by a manufacturer for technical or medical reasons to either prevent or reduce the risk of a serious incident, which is associated with a device that is made available on the market.

A FSCA may include:

• the return of a device to the supplier or a recall,
• a device exchange,
• a device modification,
• retrofit by purchaser of manufacturer’s modification or design change,
• a device destruction,
• advice given by manufacturer regarding the use of the device, such as additional information on maintenance, cleaning instructions, and training and/or the follow-up of patients, users or others,
• recommended inspections/examination by device user (e.g. regular professional checks of proper functioning in a testing setting),
• changes of software/firmware in the device, including device update.

FSCA must be reported to all Competent Authorities (CA) of the member state(s) in which the device is made available, unless the reason for the FSCA is limited to a specific country. It also applies for FSCAs that have been initiated in a third country. The member state in which the manufacturer has its registered place of business must also be informed.

The FSCA must be communicated/transmitted without undue delay for the attention of users or customers of the device in question through a field safety notice (FSN) sent by the manufacturer. The requirements for the content of the FSN are indicated in Article 89 (8) MDR.

Unless duly justified by the situation of the individual Member State (e.g. a translation error in the instructions for use that appears only in certain languages and therefore affects only specific countries), the content of the FSN must be consistent in all Member States. The FSN must be edited in an official Union language or languages determined by the Member State in which the FSCA is taken.

Which are the obligations of the distributors regarding vigilance?

According to Articles 10, 13 and 14 MDR, manufacturers, importers and distributors are required to inform competent authorities of devices that present or are considered to present a serious risk or is falsified.

‘Serious risk’ means a situation where a serious harm resulting from the use of a device that might affect patients, users or the public is likely to happen. A serious risk may include situations where the effects of the risk are not immediate.

General complaints not meeting the definition of a serious risk or a falsified device are typically not reportable.

Distributors shall also act as interlocutors with the respective NCAs and provide them with samples of the device upon request.

Distributors that have received complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device they have made available, need to forward this information to the manufacturer immediately. Distributors should also keep a register of complaints of non-conforming devices, recalls and withdrawals and keep the manufacturer informed of such monitoring.

In practice, quality agreements between the manufacturer, importer and/or distributor, as applicable, include clauses for timely communications among the parties involved in case of complaints, suspected reportable incidents and field safety corrective actions. It is common practice to stipulate that the reporting activities be carried out by the manufacturer, accompanied with proper communication with the economic operators involved.

Does it apply to ‘legacy’ devices?

According to Article 120(3) MDR, the MDR requirements relating to vigilance are also applicable to legacy devices.

The new MDCG 2023-3 also clarifies that the former guidance document MEDDEV 2.12/1 rev. 8 guidelines on a medical devices vigilance system is not applicable under the MDR.

Essence of the vigilance system

The vigilance system is essential for the safety of the patients and users and require timely participation of all economic operators and authorities involved. Timely communication among parties involved is key.

Any activities that may improve awareness of the employees of the economic operators involved, to identify potential vigilance events and clarify the notification channels available, are strongly recommended.

This newsletter is part of our campaign to increase the sensitivity and the awareness of all our business partners, to bring more clarity around the MDR journey and challenges and opportunities around the MDR Art.22 “Systems and Procedure Packs”. 

We are already today all dependent on efficient cooperation. For the MDR implementation, we require even closer collaboration to ensure we all can deliver safe supply to hospitals and patients in the future.

We are confident we will continue to supply health care competently on customized surgical procedure sets and small kits.

The next MDR newsletter will be issued in March. We wish everyone productive and pleasant days.

Do you wish to know more about specific MDR topics? Do you have any questions or comments about STS newsletter? Write us at MDR2020@stsmedicalgroup.com.