European medtech trade association MedTech Europe has urged new legislation to safeguard patient access to innovative medical technologies. The call comes after the European Council said it would begin talks with the European Parliament over the proposed EU Health Technology Assessment (HTA) regulation.

The European Council is urging the formation of a new group of national health authorities, to enable them co-ordinate on clinical assessments and scientific consultations for medical technologies.

MedTech Europe, however, asserted that: “Regretfully, it is unclear how the Council proposal, as it stands now, would contribute to better or earlier patient access to medical technology innovation.” The trade association said that the framework could interfere with assessments under the new MDR and IVDR regulations, potentially delaying patient access to innovative technologies and confusing Europe’s market authorisation process.

MedTech Europe called for criteria on assessment to be transparent and clear and said that CE marking should continue to be the only process for approval.

The body also said it was committed to working alongside EU institutions and issued three proposals. Firstly, that joint clinical assessments should be predictable, with any criteria to be transparent and adequate, assessments to be conducted at appropriate times and with “the best available and proportional evidence including real world data.”

Secondly, it called for measures to ensure that the HTA regulation would not interfere in assessments conducted under IVDR and MDR. Thirdly, that there be “a pre-defined and clear purpose for how clinical assessment reports will be used to meaningfully contribute to funding and/or investment decisions within the Member States.”

Contact us


Tel: +44 (0)1424 777745

Fax: +44 (0)1424 777746



Kirkham Young Ltd.
The Old Court House
North Trade Road
East Sussex
TN33 0EX