What does the medical devices industry include?
Medical devices, drug delivery devices, and in vitro diagnostics include a wide range of products, such as inhalers, dressings, orthopaedic implants, invasive surgical devices and drug eluting stents, blood glucose meters, test kits, and many more.
These types of products are classified as active and non-active implantable medical devices and in vitro diagnostic medical devices, whereby the classification depends on the potential risk to the patient. This in turn dictates the type of legislation required. The legislation strives to ensure that devices achieve a mandatory safety standard.
Legislation of medical devices and in vitro diagnostics
Typical compliance requirements for medical devices include:
- CE marking
- ISO accreditation
- Quality system regulation
National bodies (referred to as Notified Bodies) still govern the regulation of medical devices in their local markets, e.g. British Standards Institute (BSI) and the Medicine and Healthcare Product Regulatory Agency (MHRA) and the Food and Drug Administration (FDA) in the US.
As with most other industries within this sector, the medical device industry is being driven to deliver better, faster diagnosis and treatment for patients, as well as less invasive treatments and shorter recovery times. This has resulted in an increased number of diagnostics which detect disease earlier, offer better usability in non-clinical settings, and produces results in real-time at an overall lower cost to health service providers.
The drug delivery device industry is continuing to move towards more efficient systems of drug delivery, including in vivo eluting implants and injectable medicines. Given their “combined” nature, these products are subject to more stringent regulatory requirements, such as increased pre-clinical and clinical-trial programmes and assessment of product licensure applications — due to the nature of them being held in the body for periods of time.
Need further information?
Woodley BioReg has developed significant experience in ensuring medical devices, drug delivery devices, and in vitro diagnostic products secure product certification through robust regulatory and quality strategies, ensuring that submissions are tailored to specific needs of this class of product.
Woodley BioReg is able to provide strategic guidance and project support throughout the development and registration process — as well as at key stages of this activity — through our flexible resourcing service.