Decision on collaboration
Which medical devices can be subject to a nationally managed introduction?
All medical devices can be subject to a nationally managed introduction. However, the regional joint work focuses on new medical devices or methods that include medical devices for which there is a need for the regions to collaborate in order for the use to be cost-effective, equal and appropriate.
The products that may become relevant are defined as medical devices according to the EU common legislation for medical devices (MDR) and for medical devices for in vitro diagnostics (IVDR).
The MTP Council decides whether a medical device or method that includes medical devices should be included in the national process for managed introduction is based either on
- Horizon Scanning. Work performed by the evaluation group in collaboration with TLV
- nomination from a region or a National Program Area, NPO, conducted by the regions.
The MTP Council's assessment is made under the guidance of the prioritization criteria (see below).
What does the decision on national cooperation mean?
A decision on national cooperation means that the MTP Council will make a recommendation to the regions. The MTP Council does this when an assessment of the value of the product/product’s method is available. In most cases TLV will then make a health economic evaluation.
If a decision on national collaboration has been made, the MTP Council generally recommends that the regions wait with the introduction of the medical device until the MTP Council has had access to an assessment of the value of the device and can make a recommendation.
When a decision on national collaboration has been made, the company concerned and, where applicable, the patient association concerned will be notified.
In order for the MTP Council to make a decision on whether a medical device / method should be subject to nationally managed introduction, it is required that the medical device/method is identified as important in the horizon scanning work or that it is nominated by a region or a National Program Area.
A company can’t apply for its product to be subject to the process. On the other hand, companies can submit information about their product by answering a number of questions in the form available on TLV's website, which means that the product enters the horizon scanning process.
The MTP Council decides on national collaboration under the guidance of developed prioritisation criteria. For each medical device proposed for regional collaboration, the Council reviews the criteria and the wishes of the regions and then makes an overall assessment of whether national collaboration is needed.
Decision on national managed introduction
The health economic assessment, including the scientific documentation of benefits and risks, as well as information on the need for organizational changes, changed competence needs and so on, forms the decision basis for the MTP Council's recommendation on use. The MTP Council also assesses the information in the submitted dossier on the basis of its reliability and relevance to the decision.
In order for the medical and health economic data to be judged to be reliable, credible scientific data is needed. A credible factual basis is characterized by the compilation of data in a systematic and transparent manner and that all important steps in the work process have been documented.
If the data is not of sufficient quality, this may mean that the company has not yet been able to show that the benefit is in a reasonable proportion to the cost, so the MTP Council may then give a recommendation to the regions to refrain from introducing the product. The decision basis is assessed in relation to the ethical platform for priorities in the healthcare sector, which is stated in the recommendation.