2. Market access

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Market access 

The CE marking process is designed to assess whether a device meets the safety, quality and performance standards laid down in the regulations before a device is made available to patients. Whether the device goes on to be sold and how it is implemented in a Member State is a separate matter, depending on country-specific criteria, including relative clinical effectiveness, comparison between alternatives and price negotiations. Market access is the umbrella term for a variety of different routes for a product to reach patients.  

There is reimbursement of some Medical Devices, e.g., IVDs when they are used in patients' pathology tests, e.g., blood analyses. Some Medical Devices are also sold direct-to-consumer. Examples of the latter include pregnancy self-tests, wound care devices, or adult incontinence diapers. 

Market access for Medical Devices

Unlike medicinal products, Medical Devices and IVDs are not typically prescribed by a patient’s physician for the patient to then obtain from a pharmacy. As a result, the market access pathway tends not to share the pharmaceutical concepts of reference pricing, nor of direct reimbursement to the patient. 

Figure 1 below shows the traditional way for medical technologies to enter the market. This model is driven by medical and technological advancements and innovation. However, the involvement of patients throughout development, regulatory processes and final decisions does not have a prominent position in the process and thus whether or not a product becomes available tends to lean mostly on manufacturers' and national decision makers' individual policies. 

Figure 1: Medical and technology driven access model. MedTech Europe. Nov. 2020.