One month has passed since the date of full application of the MDR Regulation (EU) 2017/745 for Medical Devices and there are still many doubts and questions that are still waiting to be answered.
Below are the most significant guidelines in support of the MDR (EU) 2017/745 and in some cases of the IVDR (EU) 2017/746, published by the European Commission, the Medical Device Coordination Group (MDCG) and the International Medical Device Regulators Forum (IMDRF) in order to provide support for interested parties.
Information Sheet for Class I Medical Devices
Manufacturers intending to place Class I Medical Devices on the market must ensure compliance with all applicable requirements of the MDR Regulation.
We wish to remind our readers of the information sheet “Factsheet for Class I – Medical Devices” published by the MDCG which provides useful information for Class I Medical Devices, including those that change class according to Article 120 of the MDR.
Inside the document there is an interesting infographic summarising the measures needed to ensure compliance with the MDR (EU) 2017/745.
The sheet ends with a short FAQ section where details are provided, among other things, on the temporary arrangements referred to in Art. 120 MDR, operating instructions and language requirements.
Post-Market Surveillance is a critical process that allows the manufacturer to “actively and systematically gathering, recording and analysing relevant data on the quality, performance and safety of a device throughout its entire lifetime, and to drawing the necessary conclusions and to determining, implementing and monitoring any preventive and corrective actions.” (Ref. Art. 83 of the MDR).
To clarify how to use the information collected by the manufacturer, the International Medical Device Regulators Forum (IMDRF) has published the main guidelines in a document on Post-Market Clinical Follow-Up.
Due to the incomplete functionality of the EUDAMED database, the Medical Device Coordination Group has published a guideline in the MDCG 2021-08 Clinical investigation application/notification documents which provides a set of templates to be used for clinical investigations until the EUDAMED reference module is fully effective.
European Medical Device Nomenclature (EMDN)
The European Commission has published the first English version of the European Medical Device Nomenclature (EMDN) online, using the Italian Ministry’s National Medical Device Classification (CND) as a starting point. The EMDN nomenclature will be used for registration in the EUDAMED database (Art. 26 MDR).
The final version is expected to be released in the third quarter of 2021.
The MDCG has published the MDCG 2021-12 FAQ on the European Medical Device Nomenclature (EMDN) to provide more information on the matter.
On 17 May 2021 the European Commission published the Unique Device Identification (UDI) Helpdesk to help Manufacturers comply with the Medical Device Regulation MDR (EU) 2017/745 and prepare for the date of effectiveness (26 May 2022) of the IVDR Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices.
The site provides useful information to Economic Operators who must comply with the obligations and requirements of the UDI system, including the EMDN.
We wish to remind you of some of the deadlines that you should not miss for your device to comply with UDI requirements:
INCLUSION OF THE UDI CARRIER ON THE LABELS OF THE MEDICAL DEVICES (MDR ART. 123 (3) (F), ART. 27 (4)):
- Implantable Devices and Class III Devices: 26 May 2021;
- Class IIa and Class IIb Devices: 26 May 2023;
- Class I Devices: May 26, 2025.
DIRECT MARKING ON REUSABLE DEVICES (MDR ART. 123 (3) (G), ART. 27 (4)):
- Implantable Devices and Class III Devices: 26 May 2023;
- Class IIa and Class IIb Devices: 26 May 2025;
- Class I Devices: May 26, 2027.
INCLUSION OF THE UDI CARRIER ON THE LABELS OF THE IVD (IVDR ART. 113 (3) (E), ART. 24 (4)):
- Class D IVDs: 26 May 2023;
- Class C and Class B IVDs: 26 May 2025;
- Class A IVDs: May 26, 2027.
For further information read also MDR 2017/745 Medical Devices Regulation: the major changes and In Vitro Diagnostic Medical Devices Regulation IVDR (EU) 2017/746: main changes
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“Factsheet for Class I – Medical Devices”, MDCG, 29 april 2021
“Post-Market Clinical Follow-Up Studies”, IMDRF, 25 march 2021
MDCG 2021-08 “Clinical investigation application/notification documents”, MDCG, May 2021
MDCG 2021-12 “FAQ on the European Medical Device Nomenclature (EMDN), MDCG, May 2021
https://webgate.ec.europa.eu/, European Medical Device Nomenclature (EMDN) official website
https://eu-udi.zendesk.com/hc/en-150, Unique Device Identification (UDI) Helpdesk website