New Legislation Impacts Medical Device Leaflets: Technoprint Offers Solutions

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Changes in legislation from the Medical Device Directive to the Medical Device Regulations are set to have a significant impact on our medical device customers. One of the key requirements under these new regulations is that by 2028, medical device manufacturers must ensure that the national language of each territory where the medicine will be supplied is captured on the leaflet accompanying the device. This poses a challenge for manufacturers, as they must now accommodate additional languages on their leaflets, either by using larger leaflets or by adding extra leaflets to cover the required languages.

At Technoprint, we understand the importance of compliance with these regulations and are committed to helping our customers navigate these changes seamlessly. We are currently working closely with some of our medical device clients to provide tailored solutions to address the challenge of capturing additional languages on their leaflets.

Some of the solutions we are offering include:

Lighter Weight Papers: We are exploring options to move towards lighter weight papers, which can help reduce the overall thickness of the leaflet while still accommodating the required languages.

Artwork Amendments: Our team of experts is assisting customers in amending their artwork designs to efficiently fit the extra languages onto the leaflet without compromising readability or design aesthetics.

Alternative Fold Options: For cases where multiple leaflets are necessary to cover the additional languages, we are offering alternative fold options to reduce the overall thickness of the leaflet. This ensures that the leaflet can still fit comfortably within the product packaging while meeting regulatory requirements.

By offering these tailored solutions, we aim to alleviate the burden on our medical device customers and facilitate compliance with the new regulations. At Technoprint, we remain committed to delivering high-quality printing solutions that meet the evolving needs of our clients while ensuring regulatory compliance and patient safety.

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