ACIG

ENGLISH 23 companies in and around Tuttlingen, The MDR is also specifying changes affecting reusable surgical instruments – for example, risk class I is being expanded to include a new sub-category (class Ir) for reusable surgical inst- ruments. MDR Annex VIII, item 2.3: “‘Reusable surgical instrument” means an instrument intended for surgical use in cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without a connection to an active device and which is intended by the manufacturer to be reused after appropriate proce- dures such as cleaning, disinfection and sterilisation have been carried out.’ Manufacturers of relevant devices will be expected 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, disinfec- tion, sterilisation, maintenance and functional testing and the related inst- ructions for use’. Requirements of the literature search After you have become clear about equivalent devices and the data situati- on, the biggest task is the literature search itself. Over the years, and with the introduction of the MDR and various guidelines, the requirements in this area have increased and, in particular, become more clearly defined. Where- as earlier a clinical evaluation was prepared ‘to the best of one’s knowledge and belief’, nowadays there are precise specifications for the forms that the literature search, literature assessment and final evaluation must take. Here, guideline N56 of the International Medical Device Regulators Forum (IMDRF) is a useful source of good recommendations for action. First of all, it is important that the search process is transparent and traceab- le, and relies on established scientific practice. The person (or group of per- sons) who has carried out the search should be made known, and recorded in the later report. The date or timespan of the search should also be clearly de- fined, as should the period of time it covers. When a clinical evaluation is first drawn up, it is certainly advisable to incorporate as long a period of time as possible, even if it does not include all literature up to the time of creation. In the case of medical products that rely on older, already well-known procedu-