Unique Device Identifier (UDI) is a series of numeric or alphanumeric characters that is created through a globally accepted device identification and coding standard. It allows the unambiguous identification of a specific device on the market.
The UDI is comprised of the UDI-DI and the UDI-PI.
But what are the MDR UDI Requirements for disposable devices like surgical saw blades or reusable devices like surgical power tools, drill, saw and reamer?
With this UDI assignment, it is aimed to provide faster data exchange between competent authorities on post-market activities.
For MDR post-market and vigilance requirements you can read our blog “Post Market Surveillance – Chapter 7”
The UDI-DI is a unique numeric or alphanumeric code specific to a model of device and that is also used as the ‘access key’ to information stored in a UDI database.
The UDI-PI is a numeric or alphanumeric code that identifies the unit of device production.
The Basic UDI-DI is the primary identifier of a device model.
If you intend to work with GS1 as a barcode organization, you can create a Basic UDI using the GMN generator on the website, together with the company prefix you bought.
Although all barcode organizations work on the same principle, GS1 seems to be the most preferred organization in the world for now.
Go to GS1’s website and find the country you are in and get in touch.
Basic UDI-DI reference documents;
– EU Technical Documentation evaluation certificate
– EU type examination certificate
– EU product verification certificate
– Manufacturer Incident Reporting form (MIR)
– Periodic Summary Update Report (PSUR)
– Field Safety Corrective Action Reporting form (FSCAR form)
– Periodic Summary Report form (PSR)
– Trend Reporting form
You will continue with labeling and symbol placement as in MDD. Note that the UDI is an additional requirement.
The most important thing to be considered here is the manufacturer who is the only economic operator assigns and maintains a UDI and places its UDI’s on its products.
Higher levels of packaging shall have their own UDI. To put it briefly, you will create a new UDI every time you overpack the product.
*Shipping containers are going to be exempted from the requirement.
What we need to understand from this situation is that if we have a standard packaging system, we should assign a UDI to each of these packages. But let’s say we don’t have a standard packaging. We pack the product individually and the number of products in the box is always different according to the customer’s request. In this case, it will be sufficient to assign a UDI only to the single package.
If your product does not have a shelf life, you should write the date of manufacture in the UDI.
For a medical device with an expiration date, only the expiry date should be written.
A new UDI-DI shall be required whenever there is a change that could lead to misidentification of the device and/or ambiguity in its traceability; in particular, any change of one of the following UDI database data elements shall require a new UDI-DI:
(a) name or trade name,
(b) device version or model,
(c) labelled as single use,
(d) packaged sterile,
(e) need for sterilization before use,
(f) quantity of devices provided in a package,
(g) critical warnings or contra-indications: e.g. containing latex or DEHP
If you are producing a device that can be reused from patient to patient that requires processes such as cleaning and sterilization, you should mark your UDI directly on the device. You need to make sure that this UDI is permanent and is always readable.
Since surgical drills and saws are reusable devices, they need to be washed and sterilized again. So their UDI’s need be to permanent and readable.
CRITICAL NOTE: You will need to make sure that the UDI on the device is permanent. When determining the persistence method, you should be careful not to adversely affect the integrity and working performance of your device. Even if you mark on it, you should choose a different method if you are not sure about the permanence of your UDI. Considering this situation, you may need to initiate validation studies.
Class III and implantable devices still need to progress faster and more systematically as always.
MDCG 2021-19 – Guidance note integration of the UDI within an organisation’s quality management system
MDCG 2021-10 – The status of Appendixes E-I of IMDRF N48 under the EU regulatory framework for medical devices
MDCG 2021-09 – MDCG Position Paper on the Implementation of UDI requirements for contact lenses, spectacle frames, spectacle lenses & ready readers
MDCG 2018-1 Rev. 4 Guidance on basic UDI-DI and changes to UDI-DI
MDCG 2020-18 – MDCG Position Paper on UDI assignment for Spectacle lenses & Ready readers
MDCG 2019-2 – Guidance on application of UDI rules to device-part of products referred to in article 1(8), 1(9) and 1(10) of Regulation 745/2017
MDCG 2019-1 – MDCG guiding principles for issuing entities rules on basic UDI-DI
MDCG 2018-7 – Provisional considerations regarding language issues associated with the UDI database
MDCG 2018-6 – Clarifications of UDI related responsibilities in relation to article 16
MDCG 2018-5 – UDI assignment to medical device software
MDCG 2018-4 – Definitions/descriptions and formats of the UDI core elements for systems or procedure packs
MDCG 2018-3 Rev.1 – Guidance on UDI for systems and procedure packs
MDCG 2018-2 – Future EU medical device nomenclature – Description of requirements
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