The medical device industry, like most industries, is feeling the attractive pull of globalization. After all, global connections provide more business and combine innovative powers, two essential elements that are indispensable in successful med-device environments.
Nevertheless, the beckoning call of global success isn’t always easy to follow. For many medical device companies (small, medium and large) new and uncharted regulatory requirements appear as major roadblocks to global expansion. Companies interested in venturing into Europe, however, will find that European guidelines (at least those specific to med-device regulations) are well-defined and often correspond in great measure with those regulations published by major regulatory bodies in the U.S.1
Note: For companies already doing business in Europe please refer to this article’s section, For Medical Device Companies Currently Doing Business in Europe.
For instance, the European Medical Device Vigilance System Guidelines version #5 (i.e. MEDDEV-5) provides clear guidelines for application with lawful directives (AIMD-Article 8, MDD-Article 10, IVDD-Article 11), explains the salient purposes of the system itself and describes the respective responsibilities of manufacturers, IVD manufacturers, medical device users, and National Competent Authorities (who represent the various units comprised within the European Economic Area or the EEA).
Guidelines with a Purpose
Like those guidelines within the United States, the MEDDEV-5 guidelines have the primary purpose of “the protection of health and safety of patients, users and others by reducing the likelihood of reoccurrence of the incident elsewhere.”2
Additional purposes include the following:
- To conform with many of the principles and textual guidelines promoted by the Global Harmonization Task Force (GHTF);
- To introduce the database EUDAMED;
- To improve upon past revisions of the MEDDEV guidelines.
Accomplishing MEDDEV Goals
The main purposes of the MEDDEV-5 are accomplished via the European Medical Device Vigilance System which comprises system responsibilities for the following groups:
- IVD Manufacturers
- Notified Bodies
- Users, and
- National Competent Authorities
The responsibilities of these groups will be discussed in detail within this article.
As might be expected, a manufacturer in charge of medical device production has a significant list of responsibilities when he or she is seeking to conform to European Medical Device Vigilance System guidelines. These responsibilities include the following:
- Notify NCAs (National Competent Authorities) when medical device incidents occur or in regards to field safety corrective actions;
- Ensure that field safety corrective actions and incidents comply with reporting criteria (see following header for more info on reporting criteria);
- Investigate medical device incidents;
- Participate in the application of corrective actions;
- Communicate effectively with all authorized representatives (who may be located in the EEA and/or in Switzerland) in regards to incidents, MEDEV-5 guidelines and FSCAs (Field Safety Corrective Actions);
- Communicate with marketing agents in regards to transpired incidents;
- Communicate with additional agents in regards to transpired incidents;
- Submit multiple reports for incidents that encompass multiple devices (one for each device);
- Communicate with “the notified body advised of issues occurring in the post production phase affecting the certification. This would include relevant changes derived from the vigilance system;”3
- Provide reports according to the methods assigned by the European Vigilance System even when medical devices have ceased to be listed via the market;
- Submit initial AND final reports regarding medical device incidents;
- Determine the relevance of incidents that occur outside of the EEA and/or Switzerland on processes (etc.) that occur within the EEA and/or Switzerland. When an incident is determined to be relevant manufacturers should file a field safety corrective action;
- Identify a point of contact within Switzerland and the EEA where action can be taken if a manufacturer is normally located outside of these areas.
Manufacturers’ Responsibilities: Identifying Incidents According to MEDDEV-5 Criteria
Since one of the primary responsibilities of medical device manufacturers in regards to the European Medical Device Vigilance System is to report incidents that meet specific criteria, the MEDDEV-5 text divides the criteria into three parts:
1) “An Event has Occurred”4
According to MEDDEV-5 criteria, an event has occurred when:
- Device malfunctions affect the ability of a device to perform;
- Tests performed via a device result in false conclusions;
- Device promotes a patient reaction that was unexpected;
- Device promotes a side effect that was unexpected;
- A device has been destroyed;
- A device has been abused or degraded;
- Therapy that relies on the device has been offered inappropriately;
- Medical device labels are not accurate.
2) “The Device Contributed to the Incident”
According to the MEDDEV-5 criteria a device contributed to an incident when:
- Healthcare professionals opine that the device was related to the incident in question;
- A manufacturer opines (after appropriate investigation) that the device was related to the incident in question;
- Incidents similar to the incident in question have occurred.
3) “The Event Could Have Resulted in a Problem”
According to the MEDDEV-5 criteria, an event could have resulted in a problem when:
- The incident in question could possibly have resulted in a death(s);
- The incident in question could possibly have resulted in the deterioration of a patient’s health.
Responsibilities for IVD Manufacturers
IVD manufacturers are presented with unique and often complex challenges when seeking to comply with European directives that require incident reporting. An IVD manufacturer’s challenges are unique because in vitro devices do not generally come into contact with patients or users and incidents caused by in vitro device involvement can be difficult to prove. However, the MEDDEV-5 guidelines help to preclude any non-disposition to report by stating explicitly that there should “be a predisposition to report.”5
In addition to reporting possible IVD incidents, IVD manufacturers also have the responsibility to review user instructions and labels.
Responsibilities for Notified Bodies
Notified bodies act as assessors of conformance and are thus an essential part of compliance and finalized assessment results. According to the MEDDEV-5, “Notified Bodies do not play a key operational role in the Medical Device Vigilance System” but the “overall performance of the Medical Device Vigilance System is supported by the notified body activity in the following areas:
- Assessment of vigilance procedures
- Audit of the implementation of the vigilance procedures, and link with other systems e.g. Corrective and Preventive Action (CAPA), FSCA
- Assessment of the impact of vigilance issues on the certification granted
- Liaise with the National Competent Authority if required, e.g. specific investigations/audits based on a request of the National Competent Authority.”6
Since the users of medical devices are often the first to observe incidents related to device error or the first to observe inappropriate usage methods, users are absolutely indelible to the healthy ebb and flow of the European Medical Device Vigilance System. For this reason, the MEDDEV-5 has specified the following responsibilities for users:
- Report medical device related incidents to the appropriate manufacturer, or
- Report medical device related incidents to the appropriate NCA (National Competent Authority);
- Participate in the appropriate procedures that are specified by corrective action assignments.
The Responsibilities of National Competent Authorities
The responsibilities of National Competent Authorities written within the MEDDEV-5 extend past administration and into the realms and roles of liaison work and expert communication. These responsibilities include the following:
- Send report receipts to manufacturers;
- Evaluate (with the help of the manufacturer if possible and/or practicable) reports;
- Provide advice when necessary;
- Provide intervention when necessary;
- Monitor the investigations of incidents;
- Supplement, if necessary, an incident investigation;
- Help prevent additional similar incidents by providing preventative information;
- Help educate the purchasers of medical devices in regards to the MEDDEV-5 guidelines;
- Help educate users of medical devices in regards to the MEDDEV-5 guidelines;
- Encourage incident reporting.
These responsibilities are designed for best-practice incident reporting across for those who participate in the design, manufacture, quality, regulation, marketing, sales or post-market surveillance of medical devices.
For Medical Device Companies Currently Doing Business in Europe
In the online article, Making Medical Device Vigilance More Effective 7, published by the MHRA (Medicines and Healthcare products Regulatory Agency) the following is written regarding the MEDDEV-5 revision:
“Vigilance MEDDEV Rev 5, which provides best practice guidance on the interpretation of the vigilance requirements in the EU medical devices directives, is a significant revision from the previous version.”
The words “significant revision,” result in a conspicuous concern for companies with a current standing in the European med device industry because revisions to European vigilance guidelines equate to the necessity of quality system revisions. For companies facing revised procedures or processes, the following differences between MEDDEV-4 and MEDDEV-5 are worthy of note:
- Revision 5 provides improved navigation throughout the text;
- Revision 5 provides improved structure;
- Revision 5 provides definitions and an abbreviations annex;
- Revision 5 improves the methodologies used for the reporting of use errors;
- Revision 5 improves the concepts and definitions associated with Revision 4’s “exemptions;”
- Revision 5 improves recall guidelines;
- Revision 5 improves timescale guidelines related to reporting issues;
- Revision 5 provides improved guidelines for the coordination of NCA (National Competent Authority) responsibilities/actions.
Also of interest for companies with current standing in the European medical device market is the following statement from the article Making Medical Device Vigilance More Effective:
“Any manufacturer selling on the European market should make sure that their vigilance systems are updated to meet the revised guidance by 01 January 2008.”8
Regardless of whether or not a company plans on entering the European medical device industry or is already a participant, the recent MEDDEV-5 guidelines are valuable information for best-practice success.
1 This may be due primarily to conformance with GHTF (Global Harmonization Task Force) projects. 2-6 http://ec.europa.eu/enterprise/medical_devices/meddev/2_12_1-rev_5-2007-fin2.pdf
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