Borderline products are perennial issues for both regulators and industry because of their very nature – the regulatory path to market is hard to define and is inconsistent. Borderline products are those products that may, on their face, fall under more than one regulation or directive.
In the European Union, the IVD Directive that governs the regulatory market access for in vitro diagnostic medical devices, or IVDs, also includes requirements for the specific device’s technical documentation. A medical device’s technical documentation is an integral part of its regulatory approval, regardless of the type of medical device and its classification.
Of the two medical device regulations that are currently being debated in the European Union, the regulation covering in vitro diagnostic medical devices (IVDs) contains the more comprehensive changes to the EU IVD market access regulations. These updates set the stage for radical changes in many rules that IVD manufacturers currently use in their market access.
ISO 27001 enables companies and administrations to effectively implement an information security management system (ISMS). This standard shows stakeholders (clients, shareholders, partners, regulators, etc.) that the organization took full account of the security of the information systems and that the organization is engaged in a continuous improvement process.
A risk management file is an integral part of any medical devices’ technical documentation because it details the hazards and risks linked to the use of a device and how the manufacturer handled them in order to optimize its safety and performances. Manufacturers usually construct the risk management file by continuously analyzing the risks of their devices throughout the devices’ design and development stages.
On September 26, 2012, the European Commission issued its proposed revisions to the European medical device regulatory scheme to the European Parliament and to the Council. These revisions, if adopted, will have major and long-lasting impact on the medical device economic operators (manufacturer, authorised representative, importer, and distributor) around the world that import their devices into Europe. They will also modify the missions and responsibilities of the European Commission, the Health authorities and the notified bodies.
The vast majority of medical device manufacturers who seek to sell their devices in Europe must work with Notified Bodies.
To many manufacturers for whom Europe is a brand-new market, the regulatory scheme and the role of the Notified Body are sometimes difficult to comprehend.
This is because the European CE marking process is different from the medical device approval process in the United States, and a close comparison can be difficult without years of expertise in different regulatory arenas.
As economic belts tighten around the world the medical device industry is one of the hardesthit, as one of the most competitive industries. While competition has increased, medical device recalls around the world have also increased in recent years. European authorities recalled 434 devices in 2008, 611 devices in 2009, and 748 devices in 2010.
The technical file is the key to a medical device’s certification for CE marking because it contains the most important information about the device, how it works, how it is manufactured, and how it meets the applicable regulatory requirements.