The New MDR: Safety By Design And By Vigilance

Until 2020, both the MDR and MDD are effective simultaneously; one of the MDR’s focal points is the safety and performance of medical devices to prevent situation like the recent PIP-scandal. This presentation will review what we have seen so far and how the MDR is impacting the industry in this area.

Manufacturers of Medical Devices, and all other economic operators, are legally obliged to set up, implement and maintain an effective system for both vigilance and post-market surveillance. Currently, there are abundant cases where vigilance and PMS compliance are mistakenly assumed.

Pharmaceutical companies are more and more directly involved with MDs and even though MD vigilance seems similar; it differs from Pharmacovigilance. Companies with MDs needs to comply with the MDD and/or the MDR; to help them meet this goal, several Medical Device Guidance Documents (MEDDEVs) are available.

Within the MD industry, the vigilance system allows the manufacturer to improve the safety and performance of their MD(s). In addition, other means such as post-production information, feedback, and complaints from users, patients, healthcare providers, and other stakeholders are helpful tools.

By subjecting the system to an internal audit in which you evaluate its effectiveness and compliance, you safeguard yourself from third-party inspections and, most importantly, you guarantee patient safety and product performance. All too often, we encounter situations within the Medical Device supply chain in which an economic operator, manufacturer or not, is mistakenly assuming its vigilance and PMS system are compliant.

About the speaker
Jan Bart Hak

Jan-Bart Hak is heading the medical device department of ProPharma group, in Leiden, the Netherlands. He and his team provide services, internationally, in various medical device related areas such as quality management systems, regulatory affairs, clinical strategy and product development.

Prior to ProPharma Group, Jan Bart held different management positions in clinical and regulatory affairs at international oriented companies, such as Xendo, QPS and Cordis (Johnson & Johnson). He also worked at a small startup company in biodegradable medical devices. As a Medical Biologist, Jan Bart holds a Ph.D. degree in cardiac physiology.

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