Post-market

Post-market considerations in the life sciences sector

Medicinal products cannot be placed on the market without having first obtained an approval known as a marketing authorisation (MA). Medical devices require a declaration of conformity that should be affixed with a CE mark or a UKCA mark before being placed on the market.

Post-market, companies and individuals responsible for manufacturing, marketing and selling medicinal products and medical devices retain responsibilities and liabilities relating to assessing and ensuring the product’s safety.

These companies also tend to monitor the market for parallel imports. Pharmaceutical and device companies will generally wish to monitor for falsified and counterfeit versions of their medicines or devices so they can take action against the companies responsible.

For an example of the typical lifecycle of a medicinal product, which sets out the key research, development, manufacture, marketing, sale and post-market steps, see: Lifecycle of a pharmaceutical product—flowchart.

For medical devices, the regulatory regimes in the UK and EU have been reformed to impose significant obligations on manufacturers and stakeholders for the post-market surveillance (PMS) of devices. For an overview of the life cycle of a medical