MedTech Europe’s position on the Standardisation Request for the IVD and MD Regulations
Posted on 06.06.2019
MedTech Europe’s position paper aims at outlining several concerns including limited flexibility, resourcing and expected timing of the harmonisation process. The proposed process, as it stands now, is likely to be challenging for stakeholders to effectively implement. Therefore, MedTech Europe calls upon Member States, Notified Bodies and National Standards Organisations to support the integrity of healthcare system by raising these concerns to the European Commission.
The document can be found here.