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Postmarketing surveillance. Postmarketing surveillance (PMS), also known as post market surveillance, is the practice of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market and is an important part of the science of pharmacovigilance. Since drugs and medical devices are approved on the basis ...
The QPPV must reside in the EU, and should be permanently and continuously at the disposal of the MAH. Each company (i.e. Applicant/Marketing Authorisation Holder or group of Marketing Authorisation Holders using a common pharmacovigilance system) should appoint one QPPV responsible for overall pharmacovigilance for all medicinal products for which the company holds marketing authorisations ...
Current legislation. Regulation (EU) 2017/746 (IVDR) is a regulation of the European Union on the placing on the market and putting into service of in vitro diagnostic medical devices (IVD), repealing Directive 98/79/EC (IVDD), which also concerned IVD. The regulation was published in April 2017 and is closely aligned to the EU regulation on ...
Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and sale of medical devices for human use. It repeals Directive 93/42/EEC (MDD), which concerns medical devices, and Directive 90/385/EEC, which concerns active implantable medical devices, on 26 May 2021. The regulation was published on 5 April 2017 ...
Data Retention Directive: A defunct directive requiring EU member states to store citizens' telecommunications data for six to 24 months and allowing police and security agencies to request access from a court to details such as IP address and time of use of every email, phone call, and text message sent or received.
Market surveillance for products ensures that products on the market conform to applicable laws and regulations. This helps to foster trust among consumers buying products or financial services and protects consumers and professionals from harm from non-compliant products. It also helps companies that comply to stay in business and avoid losing ...
Artificial intelligence is coming. Medical technologists today are increasingly integrating AI into robotic surgery systems. These advancements involve real-time processing of data, such as ...
Medical device reporting (MDR) is the procedure for the Food and Drug Administration to get significant medical device adverse events information from manufacturers, importers and user facilities, so these issues can be detected and corrected quickly, and the same lot of that product may be recalled. Consumers and health professionals report ...
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