What does joint clinical evaluations of medical devices and in vitro diagnostics mean?
Joint clinical evaluations of medical devices and in vitro diagnostics are a systematic and planned process for generating, analyzing and evaluating clinical data on these devices at EU level. The aim is to prove the safety and performance of medical devices or diagnostics for the intended use.
This involves evaluating clinical data, evaluating the benefits and risks, and ensuring that these products meet the requirements of EU regulations. The joint clinical evaluation enables EU-wide harmonization so that the results of Member States can be shared to avoid duplicate assessments and facilitate market access.
How and where is this regulated?
Joint clinical evaluations of medical devices and in vitro diagnostics are regulated at EU level in two key legal texts:
1. Regulation (EU) 2021/2282 about Health Technology Assessment (HTA).
It was adopted on December 15, 2021 and provides the legal framework for cooperation between EU Member States in the evaluation of new health technologies. This regulation describes:
- What is meant by a joint clinical assessment (JCA)
- How cooperation between Member States is organized (via the so-called coordination group),
- What are the tasks and obligations of the European Commission, the EMA and the Member States
- and that higher risk class medical devices (IIb, III) and class D in vitro diagnostics should be jointly assessed across the EU in future.
This regulation specifies the procedures provided for in the HTA main regulation, such as:
- communication and exchange of information between the Commission (as secretariat), Member States, manufacturers, notified bodies and expert bodies,
- the timelines of evaluations,
- deadlines for submission and review of dossiers,
- preparing and updating assessment reports, and
- Requirements for transparency, confidentiality and data processing.
What is the aim of the joint clinical evaluation?
By bundling clinical evaluation at EU level, duplication of national trials should be avoided. As a result, new medical devices and in vitro diagnostics should available more quickly in several EU countries are done because national authorities can access the same scientific evidence. Harmonization in the Member States is intended to make this large economic area more attractive for manufacturers and improve their predictability. This should then also reduce the previous 27 national assessments and the associated costs through a one-time submission in an EU state. The resulting relief of the burden on national authorities and avoiding multiple checks should reduce the time until the proceedings are completed. Ultimately, this harmonised and simplified approach can, in the long term, Ensuring quality of care and health safety for our patients.
Source: https://eur-lex.e uropa.eu/legal-co ntent/en/TX T/HTML/? uri=oj:L_2 02502086 (remove space for link)
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