EU’s Requirements and Standards for Producers of Protective and Medical Equipment to be Used in the Context of COVID-19
Many Bulgarian (and Sofia-based) companies develop and produce protective and medical equipment which can be used during the fight against COVID-19. The EU has some specific requirements and regulations regarding these solutions, some of which you can find below.
The information is provided by the Bulgarian Industrial Association, which supports the businesses in Bulgaria and publishes up-to-date information on various economic and business-related issues.
- European standards for medical devices and personal protective equipment used in the context of the COVID-19 pandemic, published by CEN and CENELEC
- Decisions, legislative and non-legislative acts, published in The Official Journal of the European Union (in 24 languages, including Bulgarian)
- Conformity assessment procedures for protective equipment
- Guidance on the applicable legislation for leave-on hand cleaners and hand disinfectants (gel, solution, etc.)
- Conformity assessment procedures for 3D printing and 3D printed products to be used in a medical context for COVID-19
Further information can be found in the Discussions section of the website of the Bulgarian Industrial Association.
If you have any questions or need additional information, please contact the BIA’s team:
Veselin Iliev
Director General
International Economic Relations
Bulgarian Industrial Association
Tel.: 02 932 0954
e-mail: ierc@bia-bg.com
