MDR/IVDR Vigilance

 Vigilance Requirements: MDR Articles 87 - 90 ,IVDR Articles 82-85

Manufacturer will analyse and find out whether the incidents are serious incidents or undesirable side-effects. Serious incidents are needs to be reported to competent authority (CA) per MDR article 87 / IVDR article 82. Non serious incidents or that are expected undesirable side-effects shall be documented in trend reporting (MDR article 87/ IVDR article 83)

Timelines for reporting of serious incidents and field safety corrective actions (MDR Article 87/IVDR Article 82)

Manufacturers needs to report serious incidents to competent authorities once a causal relationship to the device has been established.

·       Serious incidents (SI) -no later than 15 days

·       Serious public health threat -no later than 2 days

·       Death or an unanticipated serious deterioration in a person's state of health the report -no later than 10 days

·       Field safety corrective action (FSCA) -Without undue delay

Manufacturer may submit an initial report that is incomplete followed up by a complete report to CA. Final report is submitted by manufacturer through electronic system. Final report shall have conclusions about the incident investigation and corrective actions.

Periodic summary reports

Manufacturer shall submit this report when below listed conditions are fulfilled

·       Similar serious incidents that occur with the same device or device type and

·       These incident root cause has been identified or a field safety corrective action implemented

·       Incidents are common and well documented

Manufacturer shall coordinate with CA and CA needs to agree the Periodic summary report format, content and frequency .

Healthcare professionals, users and patients also report the report suspected serious incidents to the CA.CA will inform the manufacturer about this incident and manufacturer will analyse and takes appropriate action if required

MDR Article 88/IVDR Article 83 Trend reporting

·       Reported in electronic system

·       Frequency or severity of Not serious incidents or that are expected undesirable side- effects

·       These incidents have significant impact on the benefit-risk analysis

·       PMS plan shall have effective methods and tools to establish any statistically significant increase in the frequency or severity of incidents within time period

MDR Article 89/IVDR Article 84 Analysis of serious incidents and field safety corrective actions

After reporting serious incident, the manufacturer shall conduct risk assessment of the incident and take any required field safety corrective action. This will be evaluated by CA.

The following factor are considered by CA while evaluating the SI & FSCA

·       Causality, detectability and probability of recurrence of the problem

·       Frequency of use of the device

·       Probability of occurrence of direct or indirect harm

·       Severity of that harm

·       Clinical benefit of the device

·       Intended and potential users, and population affected

National competent authority or the EMA scientific opinion is needed for Devices with incorporates, as an integral part, a substance(MDR)/ companion diagnostic(IVDR).

Field safety notice (FSN)

Manufacturer shall inform field safety corrective action to users through FSN. FSN shall be written in official Union language or languages determined by the Member State in which the field safety corrective action is taken.

Before informing user, FSN shall be submitted to CA .CA will provide the comments .

FSN shall be uploaded in  the electronic system and it shall be accessible to the public

FSN shall include the below information

·       Device identification including UDIs, SRN

·       Reason for the field safety corrective action

·       Malfunctioned device reference

·       Associated risks for patients, users or other persons

·       Actions to be taken by users.

MDR Article 90/IVDR Article 85 Analysis of vigilance data

Commission shall, in collaboration with the Member states analyse the vigilance data to  identify trends, patterns or signals in the data that may reveal new risks or safety concern.

if there any new risk arises then it will inform manufacturer.

MDR Article 92/ IVDR Article 87 Electronic system on vigilance and on post-market surveillance

The following reports are submitted electronically,

·       Serious incidents and field safety corrective actions

·       Periodic summary reports

·       PSURs

·       Trend Reports

·       Field safety notices

·       Information to be exchanged between the competent authorities of the Member States and between them and the Commission

References

·       REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

·       REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU