Vigilance and Post-Market Surveillance play a crucial role in the MDR compliance procedure, forming an integral part of every medical device manufacturer’s Quality Management System (QMS). Articles 83 to 92 MDR and Articles 78 to 87 IVDR address these elements of the QMS.
But what are Vigilance and PMS exactly? What are their differences? Is there any overlap between them?
Vigilance and PMS definitions and context
As previously established, Vigilance and PMS are pieces of the MD compliance puzzle, albeit important ones. Before comparing the terms between them, we must first establish their definition as per MDR:
Post-Market Surveillance is stated as “all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions” (EUR-Lex, 2017)
In simpler terms, Post-Market Surveillance refers to the manufacturer’s collection of information and experience associated with a device systematically placed on the EU market in a systematic manner.
On the other hand, while not having a separate entry in the definition section, Vigilance is termed in Article 87 as the obligation of manufacturers of devices placed on the EU market to report any incidents connected to their devices to the Competent Authorities. Additionally, to document any steps they have taken regarding these incidents (field safety corrective action), not only in the EU market but also in third countries if the devices are circulating in the EU Market.
What are the Post-Market Surveillance requirements?
Post-Market Surveillance comprises four elements, with duties that a device manufacturer placing on the EU market must fulfil to comply with the Regulation.
- A Post-Market Surveillance System as per Article 83 MDR & Article 78 IVDR. This is defined as the system through which a manufacturer obtains relevant information on the quality, performance and safety of a device they have placed on the market, with measures proportionate to the risk class and type of the device and forming a vital part of their QMS. This data should be used, among others, to:
o Update the benefit-risk determination set in the risk management;
o Update the design and manufacture information;
o Update the clinical evaluation;
o Identify the needs for preventive, corrective or field safety corrective actions;
- A Post-Market Surveillance Plan as per Article 84 MDR & Article 79 IVDR, according to the requirements set by Annex III of the Regulation.
- A Post-Market Surveillance Report (PMSR) as per Article 85 MDR & Article 80 IVDR, in cases of Class I devices. This report needs to summarize the data obtained from the abovementioned Post-Market Surveillance Plan.
- A Periodic Safety Update Report (PSUR) as per Article 86 MDR & Article 81 IVDR, in cases of class IIa, IIb and III devices. Equally to the PMSR, the PSUR must be compiled for each device as a result of the implementation of the Post Market Surveillance Plan.
Only when all of the above elements are present can a manufacturer claim they are MDR compliant with Post-Market Surveillance and that they indeed have a system that gathers and filters information related to the quality, performance and safety of their device
What are the Vigilance requirements?
As previously determined, vigilance relates to the steps a manufacturer has to take in case of any incidents involving their devices, the way they report them and the field safety corrective action measures they have to take in response.
A series of factors play a role in the way in which Vigilance is performed, both by the manufacturer and the Competent Authorities and Commission:
- Reporting of serious incidents and field safety corrective actions and their communication to the Competent Authorities in different scenarios (Article 87 MDR & Article 82 IVDR), as well as their analysis (Article 89 MDR & Article 84 IVDR).
- Reporting potential trends regarding the frequency and severity of incidents concerning the devices placed in the market (Article 88 MDR & Article 83 IVDR).
The Commission analyzes all the collected Vigilance data is analyzed with the collaboration of the Member States as a way to determine any previously unforeseen risks (Article 90 MDR & Article 85 IVDR). This is done through an electronic system through which Vigilance and Post-Market Surveillance data is gathered and through which the Commission and the Member States ensure the fulfillment of the above requirements.
Vigilance vs PMS or Vigilance & PMS? A symbiotic relationship
As observed through the explanation of the context and characteristics of these terms, it quickly becomes apparent they are meant to be complementary to each other. One would not properly fulfil its scope without the other.
Post-Market Surveillance without Vigilance would have merely been delegated to gathering information, adverse or otherwise, without a system in place to report and act when the safety of consumers is at stake.
Vigilance without Post-Market Surveillance would simply not function, as no system would exist to gather and filter information that could imply a serious incident and necessitate field safety corrective action. Nor would the Commission and Competent Authorities be able to observe any specific trends with devices on the market and succeed in averting future incidents.
The role of Obelis on Vigilance and PMS
Obelis, as European Authorized Representative, requires detailed files on PMS and Vigilance as part of the general QMS documentation needed for the MDR compliance procedures. Comprehensive relevant files ensure that the clients are compliant with MDR 2017/745 and IVDR 2017/746 and that they will continue monitoring their devices placed in the EU market. Additionally, through their Agreement with Obelis, manufacturers must provide any copies of manufacturer incident reports that were submitted to the authorities, as well as any communication that followed as a result. Consequently, a safer environment for consumers is created, or in case of incidents, a swift reporting to the Authorities is ensured, followed by actions to rectify the problems.
Are you a medical devices manufacturer interested in marketing your medical devices in the EU? Contact us now!
Nikolaos Chatzistavrou
Regulatory Affairs Department
14/10/2022
References
EUR-Lex. (5 April, 2017). 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 (europa.eu). Retrieved on 20/10/2022.
EUR-Lex. (5 April, 2017) 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 (europa.eu). Retrieved on 20/10/2022