Market Access: What regulatory approval or standards do I need to meet?
Whether your product is a medical technologies or a digital health product, meeting the industry standards or regulatory approvals is a key step in bringing your product to market. Below is a brief overview of the standards you need to be aware of when developing each type of product.
Aligning with the Medicines & Healthcare products Regulatory Agency (MHRA) is a crucial step for MedTech companies, as it specifies the regulatory framework for medical devices and specifies that they must meet the applicable ‘essential requirements’ to conform and gain a CE mark to be placed on the market.
There are currently two type of clinical studies or investigations that MedTech companies are required to follow:
- Non CE marked devices – regulatory studies
- CE marked devices – post-market surveillance studies (post approval)
Requirements depend on the classification of the device (Class I for low risk, upto Class III for high risk). In brief terms, the level of regulatory control applied to devices is meant to be proportionate to the degree of perceived risk based on who the device user may be or the effect if it fails to perform as intended.
The NICE evaluation standards framework for digital health mirrors the structure of Medtech regulations, with the level of evidence required proportional and cumulative depending on type or purpose of the digital health product. Please see a short summary below:
- Tier 1: system services such as EHR, EMR and electronic prescribing systems (little evidence requirement beyond credibility, relevance and user acceptance)
- Tier 2: Inform, communicate and general health monitoring (no firm evidence requirement but information must be accredited by NICE or NHS England, data must be collected to demonstrate value and quality and safeguarding measures must be in place)
- Tier 3: Self-management and behaviour change, therapeutic, diagnosis or active monitoring (depending on the type of product, effectiveness must be demonstrated by either observations, quasi-experimental or experimental studies with a comparison or baseline group)