What do I have to think about after the device hits the market?

Congratulations, you are marketing your device! You have successfully followed the MDR conformity assessment procedure, affixed the CE mark and are now in compliance with the MDR. There are, however, a lot of things to keep in mind when marketing a product. Some following from the MDR, others from other legislation. Do keep in mind that most rules also apply/are relevant in the pre-marketing phase.

What are the requirements of post-market surveillance according to the MDR?

According to the MDR, manufacturers are required to maintain a comprehensive post-market surveillance system, collecting and analysing data on the quality, performance, and safety of the device.[1] This involves activities such as vigilance reporting, i.e., reporting serious incidents and field safety corrective actions, periodic safety update reports, and post-market clinical follow-ups.[2] The MDR also emphasizes the importance of taking corrective actions if necessary, to protect the health and safety of patients and users. This may include device modifications, recalls, or even withdrawals from the market.

Is advertising for a medical device permitted?

Advertising can be a crucial aspect of getting the device to the relevant user. Advertising is, however, regulated. In the European Union the MDR provides rules on certain device-related claims.[3] For instance with regard to misleading information, the omission of certain risk-related information and the suggestion of uses other than those stated to form part of the intended purpose for which the conformity assessment was carried out.  Advertising is further regulated on Member State level. This means that advertising in, for example, Germany could be regulated differently than in the Netherlands. In the Netherlands, medical device advertisement is regulated partially in statutory laws on general advertisement and partially in codes of conduct with regard to general and medical device specific advertisement.

Am I allowed to provide favors to healthcare professionals?

How success rate of any product generally depends on whether its potential users are inclined to use it. This can be achieved by pricing and advertising but also by offering money, services or goods for the purpose of promoting the sale of a medical device to healthcare professionals (“Favors”). Favors can range from paying for services, participation fees for a conference, sponsoring a project, giving a product discount to a birthday present. On EU level, there is no binding regulation on favors. That being said, member of certain associations could bind themselves to codes of conduct such as the Medtech Europe Code of Ethical Business Practice. Favors are, like advertising, regulated on a Member State level. In the Netherlands, for example, favors are strictly regulated in the Dutch Medical Device Act.[4] In addition, the Netherlands knows the ‘Code of Conduct for Medical Devices’. The rules on favors in this code are comparable to the rules on favors in the Dutch Medical Devices Act, but are a bit more extensive.

What steps do I need to consider for the pricing and reimbursement of the device?

Healthcare systems and reimbursement processes can vary significantly between EU Member States. Before a medical device can be sold in a particular Member State, it not only needs to comply with the MDR, but it also often needs to go through a separate process to be eligible for reimbursement under that Member State’s healthcare system. This typically involves demonstrating the device’s cost-effectiveness and clinical benefits. The criteria for reimbursement can be highly variable and may depend on factors such as the type of device, the intended patient population, and the specifics of the national healthcare system. In some EU Member States, the price of a medical device may be negotiated as part of the reimbursement process. This can depend on factors such as the perceived value of the device and the prices of comparable products on the market.

In the Netherlands, for example, with regard to reimbursement for the use of medical devices in hospital settings, the following steps must be taken for a medical device manufacturer seeking reimbursement for its device in the Netherlands:

• In-hospital use:
o Determine if the device falls within an existing Diagnosis Treatment Combination (“DBC”) code. A DBC is an instrument in the Netherlands used to calculate and bill for the cost of hospital care. It includes all activities from diagnosis to treatment for a particular condition. If a medical device is part of a procedure that is covered under a DBC, the product can be covered and manufacturer should engage with healthcare providers to promote the adoption of their device and with insurers to negotiate prices.
o If a device isn’t covered under a DBC, the manufacturer may need to submit an application for reimbursement to the Healthcare Institute Netherlands. This body assesses whether a particular treatment (not a single medical device) should be included in the basic health insurance package based on need for treatment, effectiveness of the treatment, cost-effectiveness and feasibility. After the assessment, a new DBC can be created. Hospitals and insurers negotiate prices for DBCs. These prices aren’t fixed and can vary between hospitals and insurers.
• For devices for other uses than in-hospital use, for instance those being reimbursed based on the Dutch Health Insurance Order (in Dutch: “Regeling Zorgverzekeringswet”), negotiations should be started with health insurers. It is primarily up to the health insurance company to assess whether a (new) medical device qualifies for reimbursement from the basic health insurance package.

How to deal with making changes to the device?

Making changes to the device’s function, intended use, essential design and manufacturing characteristics may have serious consequences from a regulatory perspective. A change to or the addition of functionality may lead to the device to be qualified as a medical device (if it was not already) or a revision of the classification of the medical device.

Even minor changes should be documented, including the reason for the change, an assessment of the impact of the change and an outline for a plan for implementation. Major changes can lead to the obligation to perform a new conformity assessment procedure, including having a Notified Body assessing the device and manufacturer again.

[1] Art. 83(2) MDR.

[2] Art. 83 to 90 MDR.

[3] Art. 7 MDR.

[4] Art. 6 Dutch Medical Device Act.

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