Lorenzo Tempesti -

Starting with the entry into force of the new European Regulation 2017/745 on May 2020, the information on medical devices to be supplied by the manufacturers will be more detailed and regulated. The Annex I of the current Directive 93/42/CEE will be in part maintained even in the new Regulation, but it will be implemented with new essential requirements and an entire chapter. The chapter III “Requirements regarding the information supplied by the manufacturer” indeed, has been introduced into the Annex I of the MDR 2017/745 and it deals with this fundamental theme for the manufacturers in a more detailed and precise way.

This means that the new introduced requirements will impact, for example, on the medical devices labelling and leaflet.

The presence of CMR substances of categories 1A and/or 1 B within the allowed limits shall be labelled on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging with the list of substances.

Some other changes will interest the information to be stated on the label. In particular, the labels will have to be more detailed and shall contain the UDI carrier and the other relevant information according to the type of medical device, such as:

• The indication that the device contains or incorporates human or animal origin tissues or cells;
• The indication related to the reprocessing in case of a single-use device;
• The composition in case of device composed by substances or combinations of substances;
• The serial number for the active implantable devices.

As just anticipated, even the instruction for use shall report further information. The main novelties regard the description of the expected clinical benefits and the links remanding to the “summary of safety and clinical performance” referred to in Article 32 of the new Regulation 2017/745 (for further information on this topic, please click here) that shall be indicated in the leaflet.

Moreover, concerning the safety, the information related to any preparatory treatment or handling of the device before it is ready for use shall be stated in a more detailed manner, including the required levels of disinfection to guarantee the safety. Even the frequency and modality of maintenance, calibration, indication on the consumable components shall be described in detail.

Furthermore, another very interesting novelty regards the medical device users, who will be called to participate actively as concerns the surveillance.

In fact, the instruction for use shall contain a note that indicates to the patient/user the need of reporting to the manufacturer and to the competent authority any serious incident related to the device. Moreover there are some other information that shall be included in the leaflet such as the indication regarding the devices intended to be used by lay persons, the devices referred to in Annex XVI (for further information on this topic, please click here), the devices which incorporate electronic programmable systems and other more.

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