MedTech Europe update – Manufacturer’s Declaration on EU Regulation 2024/1860

MedTech Europe

 

MedTech Europe has released a template to assist In Vitro Diagnostics (IVD) manufacturers in complying with Regulation (EU) 2024/1860. This regulation concerns extended transitional periods and the validity of certificates issued under Directive 98/79/EC (IVDD).

The template, available for free, helps manufacturers declare their compliance and includes customizable text and a device schedule.  Authorized representatives can also use this template on behalf of manufacturers.

Download the template here and visit MedTech Europe page for more details.