The update of product group 08 insoles and product group 32 therapeutic activation devices was recently published.
BEO BERLIN supports manufacturers of medical devices with regulatory requirements.
BEO BERLIN
consulting
We can efficiently support you with the conformity assessment procedure according to MDD/MDR, the application for an HMV code and implementation of a QM system.
compiling
We can handle your regulatory requirements for you, including by preparing individual documents, evalluations, complete documentation or applications.
coordinating
We can assist you with required testing and case reports to ensure your verification procedure is fully recognised, from product testing to successful test report.
Changes in the LPPR in 2021
Update: From July 2021 on a separate individual code must be requested for each aid in France.
MDEL – Canada & Small Business Cost Reduction
Manufacturers holding a Medical Device Establishment Licence (MDEL) for Canada were contacted by Health Canada in December and the Annual Licence Review (ALR) Package was submitted with it.
EUDAMED – Actor Registration Module Operational Since December 1st, 2020
EUDAMED is the database developed by the European Commission for the registration of economic actors and their medical devices.
New Standards and Standard Projects in January 2021
DIN EN ISO 10651-5 (Project)
DIN EN ISO 11073-10101
DIN EN ISO 28399 (Draft)
DIN 33402-2
ISO 9241-971
DIN EN 10942 rev (Project)
About BEO BERLIN
BEO BERLIN advises manufacturers of medical devices on testing and approval procedures for market access.
Glossary
Your quick reference for the most important specialist terminology and keywords.
