The extension should be of sufficient duration to give manufacturers and notified bodies the time necessary to carry out the required conformity assessments. The extension should aim to ensure a high level of public health protection, including patient safety and an avoidance of shortages of in vitro diagnostic medical devices needed for the smooth functioning of healthcare services, without lowering current quality or safety requirements.
Text as published in the Official Journal, reproduced verbatim (including any typographical quirks of the source). For the authentic version, see EUR-Lex.
