To ensure effective planning and execution of a clinical performance study, it is recommended to generate a clinical performance study protocol (CPSP), also referred to as a clinical performance study plan in the In Vitro Diagnostic Regulation 2017/746.

Legacy devices continue being sold in the EEA after the current transitional period has ended.

The significance of relevant standards in clinical performance and evaluation studies for IVD and MD cannot be emphasized enough.

Request for approval of OOS.

The formality in quality risk management is not a binary concept (i.e. formal/informal).

While the pharmaceutical industry will be as affected as any other by the new Regulation on EU packaging and packaging waste, it would also enjoy some limited exemptions under the current proposals.

From the 1st of January 2023 Croatia adopted the euro.

Billev Pharma East will be present at the annual stakeholders meeting as a representative of EUCROF.