Pharmaceutical companies frequently co-package European Conformity (CE) marked medical devices with their medicinal products for patient convenience. In such instances, the medical device is placed on the market within an outer carton alongside the medicinal product.
Effect of Medical Device Regulation (MDR) on Co-packaged Medical Devices
Applicants seeking marketing authorizations (MA) for medicinal products, wherein a medical device (such as spoons, measuring cups, inhalers, or spacers) is included within the secondary packaging but does not constitute an integral part of the medicinal product, must ensure that the co-packaged medical device is CE marked in compliance with pertinent medical device legislation to sustain product marketability.
Certain medical devices may qualify for a transitional period stipulated in MDR Article 120(3a) to (3e). This provision allows devices holding a valid certificate or declaration of conformity issued under Directives 93/42/EEC or 90/385/EEC to be marketed in accordance with extended transitional periods until either December 31, 2027, or December 31, 2028, depending on the device’s risk class, provided that relevant conditions are met. The medical device manufacturer must comply with specific requirements outlined in the guidance from the “Frequently Asked Questions on MDR Transitional Provisions,” the European Commission services’ Q&A document regarding the implementation of Regulation (EU) 2023/607, and relevant the Medical Device Coordination Group (MDCG) directives.
Self-CE marked Class I devices must comply with MDR. If a self-CE marked Class I device is up-classified by the MDR, then the notified body that issued the certificate shall continue to be responsible for the appropriate surveillance in respect of all the applicable requirements relating to the devices it has certified [MDR Article 120(3b)].
As per Annex I, Chapter III, 23.1 (b) of Regulation (EU) 2017/745, the necessary information for the medical device label (e.g., manufacturer identification, lot/serial number, etc.) should be presented on the device or its packaging. However, it is acknowledged that co-packaged medical devices, particularly Class I and Class IIa (such as dosing devices like measuring spoons, cups, or syringes), may be supplied in bulk without individual packaging by the manufacturer, lacking their packaging or instructions for use (IFU), as stated in Annex I, section 23.1(d) of Regulation (EU) 2017/745. Given their small size, directly marking information on these devices can pose challenges or may not be technically feasible.
Alternate Solutions for Device Labeling
Alternate solutions can be considered to display the labeling requirements if Class I and Class IIa medical devices are co-packaged without individual packaging, and it is not technically viable to implement the labeling requirements directly onto the device itself.
Considering that the product information annexes [which include the summary of product characteristics (SmPC), labeling, and package leaflet] of the medicinal product must not include the required labeling information of the medical device, the proposed solutions below aim to provide an acceptable way to include this information.
- To provide medical device administrative information as per the MDR, a separate, additional leaflet can be included within the packaging of the medicinal product. This option will result in two separate leaflets included in the secondary packaging, i.e., the package leaflet (PL) of the medicinal product, as well as the leaflet containing the medical device administrative information. It is recommended to include a cross-reference to the other leaflet to avoid one of the two leaflets being overlooked.
This approach is not preferred when several devices are co-packaged together with the medicinal product. Having several leaflets for different devices in the same package could be confusing for the end-user.
- The leaflet containing the medical device administrative information shall be attached to the package leaflet of the medicinal product and placed within the secondary package of the medicinal product as one single folded component. To implement this option, manufacturers shall consider the following:
- The leaflet containing the medical device administrative information should be differentiated from the package leaflet of the medicinal product. This can be achieved by adding the leaflet containing the medical device administrative information as a tear-off section at the end of the printed package leaflet.
- The product information annexes (SmPC, labeling, and package leaflet) of the medicinal product, which is co-packaged with a medical device, should follow the requirements of Directive 2001/83/EC and should not include any administrative information about the device as laid down by MDR.
- The purpose of the section containing administrative information about the device should be indicated by using a relevant subheading, e.g., entitled “<Device name > specific information”.
- A fold-out vignette/sticker containing device-specific information shall be directly affixed onto the device itself or on the packaging of each device, when available. The following points should be considered when including a fold-out vignette/sticker:
- The information on the fold-out vignette should be indelible, easily legible, and comprehensible to the intended user or patient (Article 10(11) MDR).
- The risk of possible loss of information (the sticker can become loose) should be addressed.
- The adhesive should remain functional throughout the life cycle of the product (e.g., during shipping, storage in a refrigerator, or a freezer).
For more information, please refer to the official guidance provided by the European Commission. You can access the document at the below link:
Questions and answers on implementation of the medical devices and in vitro diagnostic medical devices Regulations ((EU) 2017/745 and (EU) 2017/746): [https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/questions-answers-implementation-medical-devices-vitro-diagnostic-medical-devices-regulations-eu-2017-745-eu-2017-746_en.pdf]
