Materiovigilance in EU
01 Jan 2019
“Vigilance” means close monitoring. Materiovigilance means close monitoring of any undesirable occurrence resulting from a medical device by means of having a system in place which comprises identifying, collecting, reporting, and estimating undesirable occurrences and reacting to them, or safety corrective actions after their Postmarketing phase.
The principle purpose of Materiovigilance is to improve the protection of health safety of the patients, users and others by reducing the reoccurrence of an incident.
The different activities of collecting, estimating, understanding, and reacting to new findings of the risks that arise from the use of medical devices are
- Harmful effects, in particular, on the patients/users or health care professionals
- Interaction with other substances or products
- Reduced efficiency
- Technical defects
Unlike the cases with pharmaceuticals, national competent authorities do not themselves carry out the premarket assessment of medical devices. Medical devices get conformity approval through notified bodies which are the commercial organizations overseen by the competent authorities. The competent authority designate and audit notified bodies ensure that manufacturers comply with regulations, issue guidance on particular medical devices, evaluate adverse incident reports and approve clinical investigation of devices that are designated with CE.
Medical devices are classified as Class I (low risk), Class II (medium risk) and Class III (high risk). Manufacturers self-certificate the conformity of Class-I, but for higher risk devices the assessment is done by the notified body regarding their design and quality system, the arrangements in place for postmarketing vigilance, and a review of clinical investigation studies. Notified bodies also review the product design dossier for each product before issuing a certificate of conformity for Class-III (higher risk) devices.
Performance of medical devices can be mainly affected by manufacturing failures and by the pattern of wear in long-term use. Neither of these can be detected through pre-marketing studies of feasible size and duration. Hence, postmarketing vigilance is more important.
The European database for Medical Devices (EUDAMED) is used to register data relating to manufacturers and medical devices, data related to certificates issued, modified, supplemented, suspended, withdrawn or refused. (Article 14a of MDD and article 10 of IVDD.)
The process for medical device regulation is as follows:
- Manufacturer submits a device for assessment along with plans to monitor performance of devices in use along with the response to any problem that may occur to the notified body.
- The notified body conducts a conformity assessment for approval. In case of approval ‘CE’ mark to the device will be certified to the manufacturer and the notified body also approves the system for monitoring the device’s performance and safety.
- Medical Devices with ‘CE’ marking can be recognized across all the EU member states mutually.
- The manufacturer monitors all the adverse events during the use of their device and takes necessary action which is also known as Field safety corrective Action (FSCA) to reduce the risk of death or serious deterioration in the state of health associated with the use of medical device that is placed in the market. [MEDDEV 2 12-1 rev. 8 Vigilance]
- Notified bodies also conduct periodic assessment and inspection of the manufacturer to ensure that the manufacturer continues to monitor their devices as agreed to suspend, withdraw or amend the award of CE mark. [European medical device regulation on Directive 93/42/EEC]
- Competent authorities in each EU member state monitor adverse incident report related to the device in their own country, along with the manufacturer’s investigation and responses.
- The competent authority can also take regulatory action if necessary, also approve and monitor notified bodies operating in their own country.[European medical device regulation on Directive 93/42/EEC]
Materiovigilance is designed to generate information to identity the problems related to the use of medical devices in order to facilitate the development of safety devices.
- 1. http://dictionary.cambridge.org/dictionary/english/vigilance
- 2. http://www.almbih.gov.ba/en/pharmacovigilance/
- 3. McCulloch P. The EU’s system for regulating medical devices. BMJ 2012;345:e7126.
- 4. Medicines for Human Use (Clinical Trials) Regulations 2004, SI 2004/1031
- 5. European Commission. Revision of the medical devices directive http://ec.europa.eu/health/medical-devices/documents/revision/index_en.htm [Accessed 29 November 2013]
- 6. Medicines and Healthcare products Regulatory Agency.Committee on the Safety of Devices, 2013. www.mhra.gov.uk/Committees/Devices/CommitteeontheSafetyofDevices/ [Accessed 29 November 2013]
- 7. https://www.emergogroup.com/sites/default/files/file/europe-meddev-2-12-1-rev-8.pdf
- 8. European medical device regulation based on Directive 93/42/EEC: key stages in the process.12 CE = conformité européenne; EU = European Union; MHRA = Medicines Healthcare and Regulatory