With the entry into force of the Medical Device (MDR) and In Vitro Diagnostic Regulations (IVDR) on May the 25th, 2017, new requirements impacting Post Market Surveillance (PMS) have raised interrogations amongst Medical Device Manufacturers.
While a continuous evaluation and improvement of the process is at the very heart of this change, the Regulations introduces more incisive and prescriptive measures based on device risk level for both the MDR and IVDR.
The Post Market Surveillance requirements are pretty similar for both the Medical Device Regulation (MDR) and the In-Vitro Diagnostic Regulation (IVDR) and are located in Chapter 7 of both regulations. Chapter 7 points out to specific Annexes describing more in detail the provisions relating to this topic.
Post-market surveillance (PMS) plan
The Regulation provides more details on what needs to be documented, and Annex III, for both the MD and IVD Regulations describes what information shall be included and specifies that this PMS plan shall be part of the device Technical Documentation.
A list of data to be considered is presented:
- information concerning serious incidents, including information from Periodic Safety Update Reports (PSUR) , and Field Safety Corrective Actions (FSCAs)
- records referring to non-serious incidents and data on any undesirable side-effects
- information from trend reporting
- relevant specialist or technical literature, databases and/or registers
- information, including feedbacks and complaints, provided by users, distributors and importers
- publicly available information about similar Medical Devices
and is completed in the Annex III by another list of 10 topics that shall be covered:
- a proactive and systematic process to collect information
- effective and appropriate methods and processes to assess the collected data
- suitable indicators and threshold values that shall be used in the continuous reassessment of the benefit-risk analysis and of the Risk Management
- effective and appropriate methods and tools to investigate complaints and analyze market-related experience collected in the field
- methods and protocols to manage the events subject to the trend report
- methods and protocols to communicate effectively with Competent Authorities (CAs), Notified Bodies, economic operators and users
- reference to procedures to fulfil the manufacturers obligations for PMS system, PMS Plan and Periodic Safety Update Report (PSUR)
- systematic procedures to identify and initiate appropriate measures including Corrective Actions
- effective tools to trace and identify devices for which corrective actions might be necessary
a Post-market Clinical Follow up (PMCF) plan for Medical Device or Post-market Performance Follow up (PMPF ) plan for In Vitro Diagnostics (IVDs), or a justification as to why a PMCF/PMPF are not applicable.
Post-market Surveillance Report (PMSR) and Periodic Safety Update Report (PSUR)
The implementation of the PMS plan can lead to 2 different type of reports based on the class of the device.
The first type is the Post-Market Surveillance report or PMSR:
This would apply to class I devices for the MDR and to class A and B devices for the IVDR.
The Post-market Surveillance report shall present Results and Conclusions of data gathered from the Post-market Surveillance Plan and shall include rationale and description of CAPA taken.
This report shall be updated as necessary (no frequency requirement in this article) and made available to the Competent Authorities upon request.
Here there is a slight difference between the In Vitro Diagnostic Regulation (IVDR) and the Medical Device Regulation (MDR) as for IVDs, this report shall also be made available to the Notified Body upon request.
For class lla, llb and lll medical devices and IVDs in class C and D, the Manufacturer shall prepare a Periodic Safety Update Report, also called PSUR.
As for the Post-market Surveillance Report, the Periodic Safety Update Report shall present Results and conclusion of data gathered from the Post-market Surveillance Plan, includes rationale and description of CAPA taken.
However, here the regulation adds items to be included: the conclusion of the Benefit/Risk determination, the main findings of the PMCF/PMPF, the sales volume and an estimation of the user population characteristics and usage frequency.
For the PSUR, the update frequency is set in the Regulation and an annual update is required for class IIb, III, C and D and every 2 years for class C.
The PSUR shall be part of the Technical Documentation and made available to Notified Bodies and Competent Authorities.
For class III, Implantable devices and class D, the Periodic Safety Update Report shall be submitted to the Notified Body and reviewed using the Eudamed electronic system. This implies a new type of annual review for Periodic Safety Update Report by the Notified Bodies.
Vigilance and trend reporting
The requirements for Reporting of serious incidents and Field Safety Corrective Actions (FSCA) can be found in Article 87 of the MDR, 82 of the IVDR. In these articles, we can identify that many provisions are coming from the MEDDEV 2.12-1 (rev 8) related to guidelines on a Medical Devices Vigilance System. So what was a guideline with the Directives has become requirements within the new Regulation.
As a general rule, the Manufacturer shall report:
- any serious incident involving devices made available on the Union market, except expected side-effects which are clearly documented in the product information and quantified in the Technical Documentation and are subject to trend reporting (next topic)
- any Field Safety Corrective Action (FSCA) for devices made available on the European Union market, including in some cases Field Safety Corrective Action (FSCA) undertaken in a third country in relation to a device which is also legally made available in Europe.
The Manufacturer shall take into account the severity of the serious incident to determine the timeframe for reporting it. Based on the severity of the incident, 3 different timeframes have been defined: 2, 10 or 15 days. Both the MD and IVD Regulations provide more details on each situation.
All reporting to relevant Competent Authorities shall be done using the Eudamed electronic system and data analyzed by both the Manufacturer and the member states.
The Regulation is also introducing a new requirement related to trend reporting:
For incident that are not serious incident covered by the previous article, Manufacturers shall report by means of the electronic system […] any statistically significant increase in the frequency or severity of incidents that are not serious incidents or that are expected undesirable side-effects that could have a significant impact on the benefit-risk analysis […] and which have led or may lead to risks to the health or safety of patients, users or other persons that are unacceptable when weighed against the intended benefits.
The Manufacturer shall also specify how to manage these incidents and the methodology used for determining any statistically significant increase in the frequency or severity of such incidents, as well as the observation period, in the post-market surveillance plan.
Competent Authorities may assess these data and require the Manufacturer to take action. In this case, the Competent Authority shall inform the Commission, the other Competent Authorities and the Notified Body that issued the certificate, of the results of such assessment and of the adoption of such measures.
In summary, the Regulations are more prescriptive than the Directives are on the Post-market Surveillance but also give more details about what to document and how to do so. We can see more requirements for the Manufacturers on this topic but also a greater involvement of the Notified Bodies.
Vigilance and Market surveillance complete the Chapter VII of the regulation and will be further develop in our Webinar on Post-market Surveillance:
Topic: Post Market Surveillance requirements under the new European Medical Device Regulations
Presenter: Florianne Torset-Bonfillou, Director of Regulatory, Education and Quality – Lead Auditor at LNE/G-MED North America, Inc.