Regulatory overview

Over the past 30 years, the medical technology industry has developed an amazing number of life-saving and life-enhancing products. These products and therapies have helped millions of patients to live longer, better-quality lives. With continuing innovation and the rapid advancement of technologies, medical devices are currently one of the fastest growing industries.

Due to the high standards of safety required, the medical device industry is highly regulated (see the links below for more detail). In Europe, government policies are translated into national regulations that are enforced by legislation, which forms a necessary part of a country’s overall national health system. This ensures access to high quality, affordable medical devices that can be used and disposed of safely and appropriately.

Health care-associated infection is a major issue in patient safety, even in countries with well developed regulatory and healthcare systems. Regulatory controls for medical devices therefore also play a vital role in the fight against health care-associated infections.

The role of sterile barrier systems

Sterility and its maintenance, together with the prevention of cross-infection, are at the top of any list of critical factors in patient care. The packaging around medical devices that allows those devices to be sterilised, provides a microbial barrier and maintains sterility effectively up to the point of use is known as a sterile barrier system (SBS). Sterile barrier systems are an essential part of a sterile medical device.

• Under the current regulations a sterile barrier system is defined as “the minimum packaging configuration that provides a microbial barrier and allows aseptic presentation of the product unit at the point of use”. This is distinct from protective packaging which is defined as the “packaging configuration designed to prevent damage to the sterile barrier system and its contents from the time of their assembly until the point of use.”

Traceability and safety

Manufacturing medical devices and their sterile barrier systems in a highly regulated environment can be extremely challenging and traceability throughout the whole life cycle is essential. The EU has setup the EUDAMED database to collate information about all the medical devices that are made available in the EU throughout their lifecycle, and the related companies.

In addition, there are lists of product recalls for medical devices which can be found on national regulatory agency websites in Europe, for example, on the Medicines and Healthcare Products Regulatory Agency (UK) website and on the FDA website, at List of Device Recalls in the USA.