Medical devices and drug delivery devices consist of a range of products, including inhalers, dressings, orthopaedic implants, invasive surgical devices and drug eluting stents. 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 Drug Delivery Devices
Typical compliance requirements for medical devices include:
• CE Marketing
• ISO Accreditation
• Quality System regulation
• cGMP
National 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 is resulting 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).
How Woodley BioReg can help the medical device and drug delivery industry
Woodley BioReg has developed significant experience in ensuring medical and drug delivery devices secure product licence through robust regulatory and quality strategies to ensure submissions are tailored to specific needs of this class of product. Woodley BioReg is able to provide project support throughout the complete development and registration process as well as at key stages of this activity through our flexible resourcing offer.
Please contact us for medical advice consulting and drug delivery device consulting.
