The European Commission’s Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) has published Guidelines concerning the use of phthalates in medical devices. The Guidelines concern the benefit-risk...more
On 23 July 2019, the European Commission published the draft Commission Implementing Regulation (hereafter “Draft”) regarding Common Specifications for the reprocessing of single-use medical devices....more
The European Commission has updated the Manual on borderline and classification in the community regulatory framework for medical devices (Borderline Manual). The Borderline Manual is intended to assist manufacturers in...more