ACIG

22 Parliament on 5. April 2017. Following its publication in the EU Official Journal on 5. May 2017, the new regulation came into force on 25. May 2017 featuring a three-year transition period until 2020. During this period, certifications may be issued according to both the new regulation as well as the old directives. The long-established Council Directives 90/385/EEC and 93/42/EEC will subsequently no longer apply. The MDR specifies requirements pertaining to the development, production, use and monitoring of medical devices that pose significantly greater hurdles when compared with the previous legal position. Manufacturers are facing a variety of challenges as a result of these changes, particularly those concerning the content of technical documentation, clinical evaluations and post-market surveillance. The scope of the new requirements will lead in many instances to a longer, more strict conformity assessment procedure and consequently a longer time-to-market process for medical devices. Due to the small number of notified bodies and the outbreak of the coronavirus pandemic, the entry into force of the MDR has been postponed by one year until 25. May 2021. A new regulation that replaces the two existing directives will not therefore be in place until 2021. While this means greater uniformity across the EU member states, it also entails less room for manoeuvre for individual compa- nies. The MDR also makes no distinction based on whether the device is intended for a very large market or rarer illnesses. Exceptions for niche applications, e.g. in the case of small patient groups, are expected to be few and far between. Any firm that wishes to bring medical devices to market must in future meet the re- quirements under the new MDR regulatory framework. This equally applies to the field of surgery and notably concerns all medical tech- nology companies in and around Tuttlingen, with the MDR also specifying chan- ges affecting reusable surgical instruments. Risk class I is expanded to include a new sub-category (class Ir) for reusable surgical instruments. The legislature has established more stringent requirements for these devices with respect to conformity assessment procedures. Manufacturers of relevant devices will be ex- pected to have these recertified. The manufacturer must go through a procedure in accordance with either MDR Annex IX Chapter I (quality management system) or MDR Annex XI Part A (production quality assurance) with a notified body. For these devices, the notified body’s participation in these procedures is, however, limited “to the aspects relating to the reuse of the device, in particular cleaning, disinfection, sterilisation, maintenance and functional testing and the related instructions for use.” Germany’s federal government still has work to do before the final implementation of the MDR, with the regulation necessitating changes to domestic legislation. Legislative amendments will be made in Germany on the basis of so-called dele- gated acts. The German Federal Ministry of Health has set up the National Working Group on the Implementation of the MDR (NAKI) with this in mind. Two additio- ENGLISH