The New European Medical Device Regulations (MDR) Are Coming! Don’t Panic.
On the 7th of March, the European Union (EU) Council unanimously voted for the adoption of the Medical Device Regulations (MDR) and In Vitro Diagnostics Regulations (IVDR). There is still one voting round to go at the European Parliament, but it definitely looks like the new regulations that have been in the works for years, will finally take effect by this summer. The purpose of these regulation is to harmonize various standards, and in the end, make sure that medical devices are doing what they’re supposed to do, without causing harm, and ensure traceability (which is where Microscan comes in).
What is a medical device?
A medical device is any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used for human beings for specific medical purposes: diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, injury or disability. This means that medical devices range from simple asthma inhalers to bedpans, and complex pacemakers to surgical devices, and even software in some cases.
What do the new EU regulations mean for medical device manufacturers, or their authorized representatives, in Europe?
For the companies already dealing with the FDA UDI regulations (read our whitepaper here), this will probably not come as a big surprise. For local European companies, there are a lot of preparations to be made in the coming years. Companies operating in this industry should start by putting together a transition plan as soon as possible.
The type of devices that the manufacturer plans to market, availability of clinical data, and validity of certificates all play a role in this complex topic. Companies may want to get certified as soon as possible, or wait until their existing certificates expire.
The MDR states that all manufacturers should have a quality management system and a post-market surveillance system in place which should be proportionate to the risk class and the type of the device in question. Devices will be divided into classes I, IIa, IIb and III, taking into account the intended purpose of the devices and their inherent risks. In addition, manufacturers are also required to at least one person responsible for regulatory compliance with the necessary expertise in the field of medical devices.
Another key aspect of this regulation is the creation of a European database on medical devices (Eudamed) that should integrate different electronic systems to collate and process information regarding devices on the market. This will enhance transparency, and give better access to information for the public and healthcare professionals, avoid multiple reporting requirements and facilitate the flow of information. The Europan Commission also plans to set up and manage a UDI database to validate, collate, process and make available information to the public.
What’s the deal with UDI?
The traceability of devices with a Unique Device Identification system (UDI system) should improve incident reporting, enable targeted field safety corrective actions and ensure better monitoring by authorities. It should also help to reduce medical errors and to fight against falsified devices. A UDI system will also improve purchasing and waste disposal policies and stock management by and, where possible, be compatible with other authentication systems already in place in those settings.
According to the new regulation, except on custom-made devices, manufacturer will have to assign a basic UDI-DI to the device and provide it to the UDI database together with the other core data elements to enable unique identification of devices and to facilitate their traceability.
UDI carriers, such as barcodes, will have to be placed on the label of the device and on higher levels of packaging (excluding shipping containers).
In order to provide for a smooth introduction of the UDI system, the moment of obligation to place the UDI carrier on the label of the device should vary from one to five years after the date of application of this regulation depending upon the class of the device. Distributors and importers shall co-operate with manufacturers or authorized representatives to achieve an appropriate level of traceability of devices.
The Basic UDI-DI is the primary identifier of a device model. It is the DI assigned at the level of the device unit of use. It is the main key for records in the UDI database and is referenced in relevant certificates and EU declarations of conformity.
Unit of Use DI
The Unit of Use DI serves to associate the use of a device with a patient in instances in which a UDI is not labelled on the individual device at the level of its unit of use, for example in the event of several units of the same device being packaged together.
What about label requirements?
The MDR also specifies label requirements for medical devices. The label shall bear:
The name of the device, the details for a user to identify the device, the contents of the packaging and the intended purpose of the device. In addition, the name, registered trade name or registered trade mark of the manufacturer and the address of its registered place of business, or its authorized representative, an indication that the device contains or incorporates a medicinal substance, the lot number or the serial number of the device preceded by the words LOT NUMBER or SERIAL NUMBER or an equivalent symbol, the UDI carrier, the time limit for using or implanting the device safely, expressed at least in terms of year and month.
Phew. That’s a lot of information on one label. And it goes on:
If a lot number, serial number, software identification or expiry date appears on the label, it shall be part of the UDI-PI. If there is also a manufacturing date on the label, it does not need to be included in the UDI-PI. If there is only a manufacturing date on the label, this shall be used as the UDI-PI.
The UDI carrier (AIDC and HRI representation of the UDI) shall be placed on the label or on the device itself and on all higher levels of device packaging. Higher levels do not include shipping containers.
In the event of there being significant space constraints on the unit of use packaging the UDI carrier may be placed on the next higher packaging level.
For single-use devices of classes I and IIa packaged and labelled individually, the UDI carrier shall not be required to appear on the packaging but it shall appear on a higher level of packaging, e.g. a carton containing several individually packaged devices.
If the manufacturer is using RFID technology, a linear or 2D bar code in line with the standard provided by the issuing entities shall also be provided on the label.
What about ISO 13485:2016?
ISO 13485 means that a certified organization can demonstrate that their quality system is effectively implemented and maintained. When the 2016 version of ISO 13485 is published in the Official Journal of the European Union (OJEU), it will become the EN ISO 13485 version, which can be considered the new state of the art standard and all devices placed on the European market have to comply with the new version. The European Union may want to harmonize the compliance with MDR and ISO 13485.
How can Microscan help?
Microscan knows labels and verification. When creating a barcode, we can help you select barcode software that has the capability of supporting the new requirements. During the creation of a new label, our LVS barcode verifiers can ensure that the data in your barcode is properly structured according to the specifications. You can test the structure and quality of barcodes on your printed label using an offline verifier that offers software parameters for the specific issuing agency specifications you are using. You can also decide to implement an online print quality control system to verify and grade the labels are they are being printed. In addition, our AutoVISION machine vision software and smart cameras can ensure that all the necessary information is printed and placed correctly on a label.
If you'd like to know more, request a free consultation on UDI traceability and label compliance from one of our experts.
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