MDCG has issued Q & A document to help manufacturer comply with UDI s (Unique device identification) requirement under MDR & IVDR. This guidance ( MDCG2022-7) contain near about 25 question regarding UDI rules for system & procedure packs, UDI labelling, UDI device identification, promotional packs and marketing samples. Few highlights from the guidance are as follows.
- The guidance addresses whether new UDI-DIs are required for device packaging adjustments, which includes changes in the number of devices. MDCG specifies that those adjustments might necessitate a new UDI-DI, stating that “A change in percentage amount would result in a misidentifying of the device this may cause traceability issues where incidents arise.”
- The guidance states that the UDI carrier needs to be placed on the label of the device itself and on all higher levels of packaging.
- Even minor changes in substance based medical devices such as formula quantity changes, necessitate new UDIs, as well as adding claims that the products remain the same and looks the same as the original product.
- “Any changes that may lead to the misidentification of the device or ambiguity in its traceability require the assignment of a new USI-DI (Annex VII, Part C, Section 3.9). Although these desired changes are not specifically listed in section 3.9, they may pose a risk for device traceability if the same UDI-DI is used.”
In different areas, medical devices used for marketing purpose such as in exhibition and trade fairs, the devices need not have UDIs.
Take a note that Under MDR, - UDIs must be affixed on all implantable devices and Class III devices by 26 May 2021,
- 26 May 2023 for Class IIa and Class IIb devices, and
- 26 May 2025 for Class I devices.
Under IVDR, - UDIs must be placed on the market by 26 May 2023 for Class D IVDs, 26 May 2025 for Class C and Class B devices, and 26 May 2027 for Class A IVDs.
This document covers many questions regarding UDI compliance for medical device and IVDR manufactures.Medical device manufacturer needs to check which EU regulations is applicable for the product, to sell product in EU market product should carry CE mark and as CE mark medical device consultant we understand the criticality of technical file as per the rule. Medical device manufacturer should be aware of Regulatory changes for the better results, the team of Operon Strategist medical device regulatory consulting always make sure to keep you updated. To guide our clients, we have launched monthly NEWSLETER which contains regulatory updates, so if you have not subscribed yet, then subscribe it today!
References: MDCG Q&A guidance.
