With the entry into force of the MDR there are several areas that have been revised as they are treated more roughly in the old Directive, among these there are also the information supplied with the device: in order to present the correct use of your device, each manufacturer is in fact required to affix on labels, packaging and instructions for use, all the information necessary for its use, such as the risks and benefits, operating methods, CE mark, etc. Let’s see the updates.
The new obligations of the actors
The obligations of the actors foreseen in the old Directive have not changed, however the new Regulation adds some. Here they are divided according to the reference person:
Manufacturer. The manufacturer must ensure that the device is provided with the necessary information in the official language of the Member State where the device is made available. In addition, he must ensure that the information on the label is indelible, easily legible and clearly understandable to the user or recipient patient.
Importer. The importer is required to verify that the device is equipped with the instructions for use, that it is labeled in accordance with the Regulations and that the related information is visible and not covered by any other labels. Furthermore, he must indicate on the device, on its packaging or on a document supplied with the device his data such as name, trade name or registered trademark, registered office and address.
Distributor.Before making a device available on the market, the distributor is required to verify that the CE marking has been affixed, the EU declaration of conformity has been drawn up and that the information that must be provided by the manufacturer is present. The distributor must therefore ensure that the manufacturer has carried out his duties and cannot for any reason distribute a product whose requirements have not been met.
An important novelty concerns the labels: the affixing of the UDI carrier, the alphanumeric code of unique identification of the device, which we remember must be present both in the readable format (HRI – Human Readable Information) and in the format for electronic transmission (AIDC – Automatic Identification and Data Collection).
The affixing of further details is provided only in the case of particular devices:
• The labels of reprocessed disposable devices must indicate the number of cycles already performed and any restrictions on the number of reprocessing cycles allowed.
• The labels of devices consisting of one or more substances must report the overall qualitative composition of the device and quantitative information on the main components responsible for carrying out the main action envisaged.
• Active implantable device labels should include serial and lot numbers if applicable.
The only type of packaging subject to implementation is sterile: the MDR states that information such as sterility certification and sterilization method must be present; description of the device; date of manufacture and limit of use/plant; warning that refers to the instructions for use in case of damage to the packaging or inadvertent opening; manufacturer data; possibly indication “intended exclusively for clinical investigations” or “custom device”.
The use instrcuction
As regards the instructions for use, the changes with respect to the MDD concern the affixing of the following information: expected clinical benefits and risks associated with the use of the device; summary of safety and clinical performance; date of publication of the instructions for use or any revisions; notice indicating the need to report any serious accident to the manufacturer and the competent authority of the Member State in which the user and/or patient is located; requirements regarding particular infrastructures, specialized training or specific qualifications of the user of the device and/or other people.
Additional information needs to be added in case of specific categories of devices:
- refurbished devices: notice the reusability of the device only if it has been refurbished under the responsibility of the manufacturer
- devices consisting of substances or combinations of substances: warnings and precautions relating to the general profile of interaction of the DM and its metabolic products with other devices, medicines and other substances as well as contraindications, unwanted side effects and the risks related to overdose
- implantable devices: overall qualitative and quantitative information on the materials and substances to which patients may be exposed
- devices intended for use by lay users: information on when the user should consult a healthcare professional
- devices that contain programmable electronic systems, including software, or for software that are devices in their own right: minimum hardware requirements, characteristics of IT rules and IT security measures, including protection against unauthorized access, necessary to make the software work as intended.
Considerations and declarations
Each manufacturer, in drawing up the information, must take into consideration the target users by analyzing the type of intended consumers (doctor, nurse, patient, etc.), the relative characteristics (functional capacities, levels and behavior of experience and knowledge) and the their level of training. In addition to paying attention to the end user, the manufacturer must keep in mind that, according to Article 7, “In the labeling, instructions for use, making available, putting into service and advertising the devices it is prohibited the use of texts, names, trademarks, figurative or other images and signs that could mislead the user or patient as regards the intended use, safety and performance of the device: attributing to the device functions and properties it lacks creating erroneous impressions about the treatment or diagnosis, functions or properties that the device lacks failing to inform the user or patient about a potential risk associated with the use of the device according to its intended use proposing uses of the device other than those declared as part of the intended use for which the conformity assessment was carried out ”