Competent Authorities in Europe are more structured and organized to operate on a European-wide level than ever before and they have intensified cross-border cooperation among themselves. As such, Competent Authorities have the ability to inspect the market and determine whether manufacturers have correctly affixed the CE marking to their devices and meet their regulatory obligations.
Over the last several years, there have been more inspections throughout the EEA, including random checks and on-site inspections at manufacturers and/or their Authorized Representatives. Most notably, Competent Authorities pay specific attention to manufacturers of self-declared devices, which do not need the intervention of a Third Party (Notified Body).
Both Competent Authorities and Notified Bodies are placing more emphasis on ensuring that manufacturers have implemented and maintain a post-market surveillance system. The concept of post market surveillance is not only embraced by the New Approach Directives but also by the ISO Quality Management and Risk Management Standards and US FDA Quality System Regulation.
In this article, we address the (regulatory) importance of implementing and maintaining a medical device post market surveillance system, including vigilance, and the respective roles of the parties involved.
Medical Device Post-Market Surveillance and Vigilance
The legal basis for post-market surveillance and vigilance can be found in the relevant sections of the following European Directives:
- Active Implantable Medical Devices Directive (AIMDD 90/385/EEC - Article 8 and Annexes II, IV, V)
- Medical Devices Directive (MDD 93/42/EEC - Article 10 and Annexes II, IV, V, VI, VII)
- In-Vitro Diagnostics Devices Directive (IVDD 98/79/EC - Article 11 and Annexes III, IV, VI)
In addition, the quality management standards, ISO 9001:2000 and EN 46001 (the latter which is to be replaced by ISO 13485:2003), as well as the risk management standard ISO 14971 (3), also include requirements for medical device manufacturers to conduct post-market activities.
In brief, medical device post market surveillance is not only regulatory-driven, but should also be considered as good business practice. It helps the manufacturer to obtain an understanding of the performance of the device once placed on the market and provides continuous feedback that enables manufacturers to maintain a high standard of product quality and consumer satisfaction. It also helps to minimize exposure arising from incidents through effective warning and product recall processes and procedures.
Post-market activities can be divided in two categories:
- Proactive - Post Market Surveillance
- Reactive - Vigilance
These are further described as follows: According to the Global Harmonization Task Force, Post-Market Surveillance is defined as: "the pro-active collection of information on quality, safety or performance of Medical Devices after they have been placed on the market."
Conversely, Vigilance refers to incidents that can occur with medical devices and in-vitro diagnostic medical devices, when they do not perform as intended, thereby leading in the worst case to injury or death. The medical device directives require timely, coordinated action and provision of information between the manufacturer and the Member States' national authorities in relation to (near) incidents that are related to the device.
The purpose of medical device vigilance is to protect the health and safety of persons within the EEA; evaluate incidents to prevent recurrence; determine the effectiveness of corrective actions and preventive actions; and monitor and learn from experience.
The European Commission had published a guideline which lays out the requirements of the reporting system for medical devices and In-Vitro Diagnostic medical devices. The Commission Guidelines on Medical Device System (MEDDEV) cover the following items:
- Explanation of the use of the reporting system
- Guidance on what types of incidents should be reported, including timescales for (near) incident reporting and recalls
- Format for the initial and final reports to be compiled by the manufacturer for review by the Competent Authorities
- Actions taken by Competent Authorities, including what types of incidents are communicated to Member States and to the Commission in Competent Authorities Reports
The Vigilance MEDDEV is regarded by the Competent Authorities and by most in the device industry as an excellent guideline. However, there remain some challenges with regard to communications among the Manufacturer-Authorized Representative-Distributor, and also among the respective Member States' Competent Authorities. It has been suggested that the lack of manpower available within some of the Competent Authorities for the implementation and timely follow-up in (near) incident reporting may explain why these challenges are still pending.
Parties Involved in the medical device post market surveillance system
The onus of post-market surveillance for medical devices is assigned to Competent Authorities, Custom Officials, Notified Bodies, Manufacturers, Authorized Representatives, Importers/Distributors, and Users. In addition, External Quality Assessment Schemes, hereafter called EQAS, is one mechanism to carry out post-market surveillance by maintaining and improving the analytical quality and medical appropriateness of clinical laboratory data.
In order to ensure that medical device and IVD post-market surveillance is carried out and conducted effectively, all parties involved must understand and be aware of their responsibilities and liabilities in this regard. The effectiveness of the system can be determined and inspected by Notified Bodies and Competent Authorities.
Market surveillance is mandated under the New Approach Directives, including the IVDD, and is enforced to ensure that the provisions of the directive are complied with throughout the EEA. EU Member States must appoint authorities to be responsible for market surveillance. For IVD post market surveillance, these authorities, also known as Competent Authorities, are usually the national Ministries of Health, which were also before the New Approach responsible for the monitoring of medical products on the market. Competent Authorities are also responsible for taking the appropriate steps to ensure that any information brought to their attention regarding adverse incidents is recorded and evaluated.
In case of an incident or random audit, the Competent Authority may require access to the manufacturer's Declaration of Conformity and Technical File/Dossier. The manufacturer, his Authorized Representative or importer, must be able to provide the Technical File/Dossier upon request to the Competent Authority. If the product is found to be non-compliant, corrective action will depend on and be appropriate to the level of non-compliance.
It should be noted that the Competent Authority will hold accountable the person (in most cases, the manufacturer) who was responsible for affixing the CE marking to a non-compliant product. Others who are responsible for the non-compliance of the product will be held accountable as well. Penalties, which may include draconian sanctions such as imprisonment, are determined by national law.
Competent Authorities are able to monitor products placed on the market by either of the following means:
- reviewing product claims
- evaluating and investigating reported complaints
- auditing Notified Bodies
- exchanging information among Competent Authorities
- visiting commercial, industrial and storage premises on a regular basis
- visiting work places and other premises where products are put into service and used
- organizing random audits
- acquiring samples of products and subjecting them to examination and testing
- disclosure of all necessary (technical) information