Your specialist for medical device vigilance
European medical device law (MDR) stipulates the need for a vigilance system (medical device monitoring and reporting system) to supplement the pre-marketing conformity evaluation of medical devices and general market surveillance. It is meant as a reactive safety concept and thus contributes to ensuring an appropriate level of protection for patients, users and third parties.
The underlying consideration behind the vigilance system is that, given the necessarily limited predictive nature of the tests and evaluations undertaken prior to the marketing of medical devices, certain problems only become apparent after the more widespread use of a device and then require an appropriate response.
A vigilance system involves efficient risk management in the individual case and prevents the recurrence of a similar problem with similar products from other manufacturers.
This can be achieved by the exchange of suitable information and an improved state of knowledge about safety-relevant aspects of medical devices. A functional vigilance system oversees and manages incidents (malfunctions, failures, or changes in specific performance, as well as any specific features or errors in the certification of medical devices) that have led, could have led, or could lead directly or indirectly to an adverse effect on a patient’s state of health.
Main aspects of the vigilance system for medical devices
- Systematic product monitoring in the market by the manufacturer
- Reporting of serious product problems to the responsible authority
- Official recording and assessment of reports
- Implementation of corrective measures (where necessary)
- Provision and exchange of information.
In Germany, the medical device monitoring and reporting system is defined in greater detail in the Medical Devices Safety Plan Ordinance (MPSV). Supplementing the provisions of the German Medical Devices Act, the Ordinance governs the rights and obligations as well as the cooperation with the authorities and specialists concerned to ensure efficient risk prevention. Professional operators and users of medical devices as well as the distribution chain are also included in the system. Effective patient and consumer protection assumes that all parties concerned work together responsibly and fulfil their obligations correctly.
To meet the constantly evolving requirements in the market surveillance of medical devices and IVDs, we also offer comprehensive services for ensuring vigilance compliance in this field. We assist you with your risk management throughout the lifecycles of your medical devices in accordance with ISO 14971 up to the adoption of the safety officer’s responsibility.
orangeglobal’s service portfolio in the field of medical device/IVD vigilance
1. Vigilance management
- Implementation and maintenance of a vigilance system for medical devices an IVDs
- Safety officer in accordance with Medical Device Directive (MPG), MDR, IVDR
- Coordination and ensuring that incidents are reported to the responsible authorities
2. Post-marketing surveillance
- Active market monitoring after product launch
- Complaint handling
- Authority notifications
- Regular systematic literature monitoring
- Post-market clinical follow-up
- Support in the continuous monitoring and evaluation of the risk/benefit ratio
3. Risk management in the field of medical device/IVD vigilance
- Development of a risk management system
- Medical technical support for risk evaluation
- Presentation of risk analysis and risk evaluation
- Implementation of corrective or preventive measures
- Monitoring of the implementation and efficacy of preventive measures
- Risk research database
- Fulfilment of statutory risk evaluation requirements
- Conducting of internal audits to monitor efficacy (risk management)
Other services in the field of medical device/IVD vigilanceWe support you in implementing the new Medical Device Regulation (MDR) and In-vitro Diagnostic Regulation (IVDR) which will replace the previous directives 93/42/EEC Medical Device Directive (MDD), 90/385/EEC Active Implantable Medical Devices (AIMD), and 98/79/EEC In-vitroDiagnostic Directive (IVDD). Every manufacturer of class I to III medical devices or class A to D in-vitro diagnostics needs to come to terms rapidly with the new requirements. The effects are far-reaching and concern medical devices and IVDs of all classes. Now, for the first time, devices that are not medical devices will also be governed by the Medical Device Regulation (MDR). Changes include the classification of devices, previous “essential requirements”, technical documentation, clinical data, market surveillance and the quality management system. European registration is uniformly regulated and involves marked changes depending on corporate objectives. Far-reaching changes are engendered by the new scrutiny procedure, the requirements for reprocessing and the introduction of the European database, Eudamed. orangeglobal helps your company to address the new requirements of the Medical Device Regulation (MDR) and In-Vitro Diagnostic Directive (IVDR)and sees itself as your partner in handling demanding tasks with a high level of quality. Medical device/IVD vigilance - your added value with orangeglobal Benefit from our many years of experience in the field of medical device/IVD vigilance and the introduction and optimisation of vigilance systems. We look forward to supporting you with this fundamental building block for the successful introduction and internationalisation of your medical devices.
Your contact person:
Frau Dipl. Biol. Jana Wolkow
Project Manager Regulatory Affairs
Tel. +49 (0) 731 954 95 - 511
Herr Ferhat Sönmez
Client Relationship Manager
Tel. +49 (0) 731 954 95 - 657