Rollout of EU Reference Laboratories for Class D IVDs

As part of BSI Regulatory Services, Medical Devices commitment in maintaining IVDs manufacturers up to date on the EU regulatory framework developments, we issue this communication in regard of the rollout of EU Reference Laboratories and oversight of Class D IVDs in Europe. On 5 December 2023, five EU reference laboratories (EURLs) have been designated through Commission Implementing Regulation (EU)…