Those who manufacture, sell, or dispense class III high risk medical products in the EU have until this May to comply with regulations outlined in the EU MDR.
There is hardly any other sector that faces such complex requirements regarding product information and labelling as the pharmaceutical industry.
The next deadline in the FDA's Unique Device Identification (UDI) regulation will hit September 24, 2016 – and it's not just about your medical device packaging anymore! Register here.
With a deadline approaching in September 2016 for compliance with Unique Device Identifier (UDI) regulations, we in conjunction with our partner Microscan have put together some useful information on what exactly is involved.
With the publication of the Delegated Act on safety features, those who manufacture, sell, or dispense medications in the European Union (EU) have until February 2019 to comply with complex new track-and-trace regulations outlined in the Falsified Medicines Directive (FMD).
New regulation introduces ‘safety features’ on the packaging of medicines for human use
The Falsified Medicines Directive (FMD) incorporates a number of initiatives to safeguard the pharmaceutical supply chain in Europe. Read the latest update here.
The UDI system, which will be phased in over several years, offers a number of benefits that will be more fully realised with the adoption and integration of UDIs into the health care delivery system. UDI implementation will improve patient safety, modernise device postmarket surveillance, and facilitate medical device innovation.
Over the past few months it has emerged that the original compliance deadline of January 2016 has been pushed back to 2018. Wrestling with the technical and logistical challenges of implementation, those on the production floor could be forgiven for losing sight of the bigger picture, which is the need to safeguard patients and consumers against the danger posed by illicit medicines.