The gaps between the new EU legislation on in vitro diagnostics and the on-the-ground reality.

The background to this debate is now well-known: an EU policy decision to tighten controls on the devices and diagnostics sector led to the adoption of a regulation in 2017 with a schedule for implementation over coming years - a timetable extended still further by last-minute legislation in early 2022, to provide the sector and regulators with more time to adapt to the changes. Discussions among experts organised in April by the European Alliance for Personalized Medicine (EAPM) exposed continuing challenges that cannot be fully resolved by the recent deferral of implementation deadlines. One salient problem is that there is little awareness of the In Vitro Diagnostic Regulation (IVDR) across Europe, and only limited awareness of the different structures of national systems involved in implementing IVDR, with consequent risks for patient and consumer access to in vitro diagnostics (IVDs). The tentative conclusion from these consultations is that despite a will across the sector to seek workable solutions, the obstacles remain formidable, and the potential solutions so far proposed remain more a matter of aspirations than of clear pathways.

Paranasal sinus and midfacial reconstruction.

Midface defects pose the most difficult of the facial reconstruction problems. Current reconstruction relies heavily on microsurgical techniques, among which there are numerous possibilities. Although midface defects frequently extend to the upper and lower face, often an awareness of the midface subunits most involved can be of critical importance. This article presents an approach that will help the surgeon to identify the defect-related problems, prioritize the reconstructive goals, and select the best surgical option in the total patient context.