In September 2013, the EU Commission published Recommendation 2013/473/EU, which details some requirements for notified bodies when performing the systematic unannounced audits. One of these requirements is to sample products at various stages of their production and test them to ensure their compliance.
The path to market approval for a medical device in the EU is no simple decision for a manufacturer to make. The Medical Devices Directive, for almost every device class, gives manufacturers a choice as to which conformity assessment they would like to use.
Mobile health apps and medical device software represent a booming market. Many mobile health apps are sold through smartphone app stores. At the same time, more and more medical devices are connected to hospital networks for the purposes of remote maintenance or periodic monitoring of their functioning.
Brazil’s medical device market expanded at double-digit rates through 2011-2013, and is expected to continue this rate as 2014 turns into 2015. About 80% of medical products in Brazil are imported. As a member of the IMDRF, and as a nation included in the Medical Device Single Audit Program (MDSAP), Brazil has made strides to open wider its medical device market to the rest of the world.
Clinical evaluations are an integral support for a medical device’s regulatory conformity and its technical file for CE marking. A medical device manufacturer uses the information in the clinical evaluation to prove that the medical device meets the applicable essential requirements. As a result, the clinical evaluation is often the largest and most complex portion of a medical device’s technical file, and it’s easy to go astray and not show that the device meets the requirements. Unfortunately, it’s usually a big setback for a manufacturer when this happens, as it may need to get more research or run more studies in order to show compliance.
Mexico is the largest medical device importer in Latin America and is a key market for medical device manufacturers not only in North America but also around the world. Mexico’s medical device registration regulations may seem complex, and they are mostly only published in Spanish. Compared to other countries in Latin America, however, Mexico harmonized its medical device regulations to ensure that the Mexican health care system has access to the same state-of-the-art technology as many others do. In addition, as a result of NAFTA, the North American Free Trade Agreement, imports into Mexico from the United States and Canada enjoy no tariffs. However, companies in Belgium, china, France, Germany, and Japan also import many devices to Mexico.
Transferring, or changing, a notified body is no small decision for a medical device manufacturer. The notified body can be seen as a partner in the manufacturer’s certification for their medical devices, so there is a lot riding on the relationship. Regardless of the reasons for transferring, however, manufacturers can freely transfer between notified bodies.
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.