June 4th, 8th and 23rd, 2021, new guidance documents were released by the Medical Device Coordination Group (MDCG). These new documents clarify the status of the Appendixes E-I of IMDRF N48 under the EU regulatory framework for medical devices (MDCG 2021-10), provide guidance on implant card “Device Types” (MDCG 2021-11), answer frequently asked questions on the European Medical Device Nomenclature (MDCG 2021-12) and provide Questions and Answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR (MDCG 2021-13).
MDCG 2021-10 The status of Appendixes E-I of IMDRF N48 under the EU regulatory framework for medical devices.
This guidance explains that the MDCG endorses the principles laid out under Appendices E – I of the IMDRF N48 guidance document (Unique Device Identification system (UDI system) Application Guide). The guidance provides clarifications as to how certain principles and examples outlined in N48 Appendixes E-I apply under the MDR/IVDR.
MDCG 2021-11 Guidance of Implant Card – “Device types”.
Article 18 (a) of the MDR 2017/745 states that the manufacturer of an implantable medical device shall provide together with the device, information allowing the identification of the device, including the device name, serial number, lot number, the UDI, the device model, as well as the name, address, and the website of the manufacturer. MDCG 2019-8 lays down some instructions on how to address this requirement and includes the statement that the implant card should also indicate a “device type” for the implantable medical device in question. This new MDCG guidance thus provides a non-exhaustive list of implantable medical “device types” in order to aid manufacturers in allocating an appropriate term for this requested information.
MDCG 2021-12 FAQ on the European Medical Device Nomenclature (EMDN).
This document provides insights with regards to the European Medical Device Nomenclature (EMDN), how it operates, who can use it and where to access the EMDN. A first version of the EMDN was released on May 4th, 2021. The second version of EMDN will be released in Q3 2021. In this second release, new terms and descriptions for medical device software (under Categories J, W and Z) will also be rolled out. The entirety of the EMDN is accessible to all stakeholders, free of charge, and can be accessed and downloaded in pdf and excel format. It is important to remember that you must always assign the most granular and terminal term available (lowest level in the tree) to your device.
MDCG 2021-13 Questions and Answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 MDR and Articles 28 IVDR.
This document addresses questions relating to the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 of MDR 2017/745 and/or Article 28 of IVDR 2017/746. It also clarifies the cases where an Actor ID is issued instead of an SRN. In this document, in question 4, it is clearly stated that manufacturers and authorised representatives of non-EU manufacturers, of only legacy devices (defined as devices which are placed on the market after the MDR and/or IVDR date of application by virtue of the transitional provisions) will have to register as actors in EUDAMED. Registered manufacturers and authorised representatives of only legacy devices are assigned an Actor ID that is not an SRN.
This document also clarifies that manufacturers and authorised representatives of non-EU manufacturers, of only “old” devices (defined as devices placed on the market according to the medical devices Directives or the in vitro diagnostic medical devices Directive before the date of application of the MDR and IVDR) will have to register as actors in EUDAMED in case serious incidents reports or field safety corrective actions in respect of the device are requested by the Member States to be reported in EUDAMED. Registered manufacturers and authorised representatives of only old devices are assigned an Actor ID that is not an SRN.
On July 12th, 2021, a first revision was made to the document and an additional question regarding the obligations to register as an Importer when carrying out activities mentioned in Article 16 of the IVDR and/or MDR was answered in the document.
What does this mean to you?
You are strongly advised to read and act upon the MDCG guidance documents that may be applicable to you and/or your devices.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.
