BIO Deutschland gives talk on the EU’s new IVD regulation
As part of a workshop on in vitro diagnostics (IvDs) in Hennigsdorf, a representative from BIO Deutschland's office gave the some 40 participants an overview of the new legal framework within the European Union. Afterwards, the workshop attendees discussed the key changes and how these will impact businesses. In addition to an entirely new classification scheme, manufacturers must prepare themselves for more stringent conformity requirements and monitoring arrangements as well as for further changes. The regulation will enter into force after a five-year transitional period that ends in May 2022, at which point manufacturers must meet the new requirements in order to receive CE certification.