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Once a device has received a CE mark, it is possible to sell, lease, lend or gift the product in Europe
Relevance:Devices and Diagnostics
In the UK, the NHS will consider a device’s clinical and cost-effectiveness before it will be reimbursed (paid for by the NHS). This may be done at national, regional or organisational level depending on the product; it is important to note that there is no funding direction associated with a NICE evaluation
Relevance:Devices and Diagnostics
Most medical devices and diagnostics do not require assessment at the national level before being considered by the local commissioner or provider, however it is possible to have a health technology assessment performed by NICE and guidance published to support uptake of your diagnostic
Relevance:Devices and Diagnostics
If you do choose to put your device forward for NICE assessment, the Medical Technology Advisory Committee will consider new and innovative devices taking into account the clinical and cost effectiveness evidence before routing the application to the relevant assessment programme MTP, DAP, IPP or TAP
Relevance:Devices and Diagnostics
Some devices associated with specialised services are reimbursed by NHS England at a national level with a funding mandate for specialised commissioners. Specialised services are those provided in relatively few hospitals. Specialised Services Clinical Reference Groups (CRGs) decide which products to put forward for consideration by NHS England
Relevance:Devices and Diagnostics
The reimbursement route for a device or diagnostic depends on who is the commissioner/provider of services for that target patient population. If there are multiple target populations (e.g. some specialised and others not) reimbursement decisions may be required from different bodies for each population
Relevance:Devices and DiagnosticsDigital
Real world evaluation demonstrates how patient outcomes and cost effectiveness are delivered in a local health population, often referred to as test beds or pilots
Relevance:Devices and DiagnosticsDigital
Phase IV trials take place once new medicines have passed all previous stages and received marketing authorisation. They involve the safety surveillance and on-going technical support of a drug after it receives marketing authorisation, designed to detect rare or long-term adverse effects over a larger patient population and time period (usually at least two years)
Relevance:Pharmaceutical
Phase IV trials can include post-approval commitments, interventional and non-interventional actions; these feed into pharmacovigilance activities and broader safety management as well as supporting reimbursement decisions
Relevance:Pharmaceutical
Companies are required to submit a risk-management plan (RMP) to the European Medicines Agency (EMA) when applying for a marketing authorisation; this may relate to post-authorisation measures (PAM)
Relevance:Pharmaceutical
If your product is classed as a medical device it will need to follow the appropriate medical device regulatory procedure: in the EU, manufacturers/developers of medical and diagnostic devices must demonstrate that they conform with the requirements outlined in the relevant European Directive before the product can be freely marketed in Europe; a CE mark is a key indicator (but not proof) of a product’s compliance with EU legislation
Relevance:Digital
Your product is likely to be classed as a medical device if it is an accessory to a medical device or meets the criteria specified in the European Commission Medical Device regulatory framework MEDDEV 2.1/6; the MHRA can also advise on this
Relevance:Digital
Class I medical devices must be registered with the competent authority (MHRA in the UK) before a CE mark can be granted
Relevance:Devices and DiagnosticsDigital
The requirements and assessment process varies by class of device, but will involve approval by a European notified body; you can choose to be assessed by a notified body in any European country
Relevance:Devices and DiagnosticsDigital
Non-sterile, non-measuring Class I devices can self-certify by writing a statement and applying to a notified body to approve
Relevance:Devices and DiagnosticsDigital
Other Class I and Class II-III devices (or those that measure) must undergo a conformity assessment by a notified body as well as complying with quality standards (e.g. ISO 13485, 14971, IEC 62304) and data protection regulation, including the upcoming General Data Protection Regulation; risk management standard relevant to medical devices is ISO:14971
Relevance:Digital
Accessories to medical devices must also complete the same requirements as medical devices themselves
Relevance:Devices and DiagnosticsDigital
Going forward, some of these regulatory requirements may be flagged during Stage 1 of the NIB Workstream 1.2 assessment
Relevance:Digital
FDA regulations will be applied to “only those mobile apps which are medical devices and whose functionality could pose a risk to a patient’s safety if the mobile app were to not function as intended” and these have been termed Mobile Medical Apps. These apps are defined as those that meet the FDA definition of device and either intended:
- to be used as an accessory to a regulated medical device;
- or to transform a mobile platform into a regulated medical device.
- “Software applications that run on a desktop computer, laptop computer, remotely on a website or “cloud,” or on a handheld computer may be subject to FDA device regulation if they are intended for use in the diagnosis or the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man”
Relevance:Digital
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