Following the global trend in handling the traceability of medical devices, the EU Commission has clearly defined the requirements for implementation of a Unique Device Identification (UDI) System in the final text of the new EU Medical Device Regulation (MDR) 2017/745 and the In Vitro Diagnostic Medical Device Regulation (IVDR) 2017/746, published at the beginning of May. Both legislative acts describe similar requirements for the two types of devices, having only the implementation timelines different.
Since the Medical Device Directive (MDD) has no provisions on the traceability of medical devices, the UDI requirements described in the MDR are completely new for the EU market and many organizations dealing with medical devices are already wondering what exactly they would need to do to become compliant. So what do you need to know about the new requirements? Here is a quick overview of the new EU UDI.
The UDI system and the compliance requirements for all medical device industry stakeholders are described in several articles and annexes throughout the MDR. The widespread appearance of the UDI through the legislative text reflects the complexity of the UDI system. A complexity coming from the multiple regulatory processes that are affected and would have to incorporate UDI information in the future. These processes impose new requirements on all actors of the supply chain, from manufacturers down to healthcare professionals, with the involvement of notified bodies (NB) and competent authorities (CA). The final goal: to improve patient safety through better traceability and transparency.
Although some time is still available before compliance is mandatory, organizations dealing with medical devices should prepare in time as the requirements are completely new and they might span the entire quality system. Very briefly, the new EU UDI requirements can be classified into three categories
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Labeling Requirements
UDI information must be placed on the label and/or package of medical devices. The UDI produced for a device comprises a UDI-DI (device identifier – specific to a manufacturer and device) and a UDI-PI (production identifier – identifies unit of device production). The composition of the UDI is common with the FDA UDI implementation and IMDRF description. The representation of the information placed on the label also follows the formats used globally: the UDI carrier must be available in both AIDC (automatic identification and data capture) and HRI (human readable interpretation) formats. More specific requirements on labeling and several device types are available in Annex VI, Part C of the MDR.
- Data submission requirements
The manufacturer will have to submit to a central UDI database, along with the UDI-DI, information relating to the medical device and manufacturer. Details on the exact information to be submitted are available in Annex VI, Part B. The core data elements included in the submission are in line with the ones required by the FDA’s GUDID, with minor differences (i.e. single registration number, containing latex or specific substances, other optional data).
EUDAMED will be the central European database used in collecting information about medical devices. Currently, EUDAMED is available only to competent authorities and notified bodies. For compliance to the EU MDR, the functionality of the database will be expanded to include not only UDI registration requirements but also registration of other information including medical device post-market follow-up, safety and clinical information, manufacturer’s registration and others.
The UDI-DI will act as a key to the system, connecting all the information regarding a medical device available throughout the European electronic system. Patients and healthcare professionals (or any other economic operator dealing with medical devices) would be able to identify UDI information from the label and access EUDAMED to obtain more information on the clinical and safety performance of the targeted medical device. NBs and CAs would have a simple method of communicating relevant information between each other.
- Storage/traceability of UDI information
UDI information assigned to medical devices would have to be tracked by manufacturers, authorized representatives, importers and distributors and in some cases, also by healthcare institutions and professionals. This implies that economic operators would need to modify their quality management system to ensure information is not lost but stored in a proper, systematic way.
Requirements for traceability are outlined throughout Chapter III: Identification and traceability of devices, registration of devices and of economic operators, summary of safety and clinical performance, European database on medical devices. All stakeholders should be able to track who supplied and/or to whom they supplied a medical device. Besides the system required for traceability, the technical documentation on the products would need to be updated (e.g. technical file – Annex II, Declaration of Conformity – Annex IV, point 3, etc.).
The approach in the EU implementation of the UDI system is risk-based (as recommended by IMDRF and implemented in the USA). Based on the current status of the EU legislation, the timeline is as follows: Class III and the implantable device must be compliant by 2021, Class IIa and IIb devices by 2023, whereas Class I by 2025. For IVDs, the implementation will also be risk based but delayed the implementation of the IVDR timeline will be different. Class D devices should be compliant by 2023, Class C & B devices by 2025, while Class A devices by 2027. These compliance deadlines are subject to change as a fulfillment of the requirements is dependent on the progress of the EUDAMED implementation and its availability.
So how can you become compliant on time? A good place to start is by taking a good look at the processes in your organization. Assess the gap and make a plan to adjust your procedures to include UDI labeling, data submission and information tracking requirements.
Should you need any help in identifying UDI requirements applicable to your organization, Qserve would be more than happy to help!
Alexandra
Should you want to read more about this subject, Alexandra has also written a blog about "FDA UDI – Class I deadline extended".
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