In order to fix inconsistencies, errors and slightly correct the European Medical Device and In Vitro Diagnostic Regulations (MDR and IVDR, respectively), two corrigenda have been published in the Official Journal of the European Union on May 3rd. Corrigendum to Regulation (EU) 2017/745 and Corrigendum to Regulation (EU) 2017/746.
Despite that these new publications do not modify any previously established transition deadlines as someone may have expected or hoped, they shed some light on areas where there may have been some confusion or further clarification was needed. As for the MDR, it brings 14 corrections; ranging from wording or grammatical changes, to others that may have more impact; as the change in Annex VIII, Section 3.2, which now reads “Accessories for a medical device shall be classified in their own right…” instead of “Accessories for a medical device and for a product listed in Annex XVI shall be classified in their own right…”. With regards to the IVDR, the 17 new implementations include those minor amendments to match MDR corrections and others, such as the introduction of the international standard ISO 20916 on clinical performance studies using specimens from human subjects when disclosing that the “rules on performance studies should be in line with well-established international guidance in this field” in recital (66), which is currently under development.
Besides, and at the same time, few more guidance documents have been released to better explain which data from Medical Device and IVD Unique Device Identifier (UDI) will be required to be included in the EUDAMED database. EUDAMED UDI Device Data Dictionary and MDR – UDI and device data sets to provide in EUDAMED for Medical Devices, and IVDR – UDI and device data sets to provide in EUDAMED in case of IVDs; together with the MDCG 2018-1 v2 Guidance on basic UDI-DI and changes to UDI-DI, which was released on May 8th.
The dictionary document is intended to give an understanding over the data that is to be provided to EUDAMED and that can be communicated through Data Exchange process for the UDI/Device module. The document presents the different attributes related to UDI/Device that may be communicated through XML, their correspondence to the fields from EUDAMED User Interface, the description of each field apart and the Rules applying at the level of the Entity of for each specific field apart.
In addition to the manufacturer name and Basic UDI-DI value, the MDR UDI and device data sets guidance highlights the requirement of indicating if the device is implantable, active, a reusable surgical instrument or intended to administer or remove a medicinal substance, among others. Similarly, in the IVDR guidance the requirement for information on whether the IVD is for self-testing or for professional testing, or if it is a companion diagnostic or a reagent, is remarked too.
Magellan Device Compliance Platform is abreast of the latest news in the European market, please contact our team and meet us at RAPS Regulatory Conference – Europe (Brussels, Belgium from 13 – 14 May 2019), for more details on how Magellan can keep you aware of them!