The pharmaceutical industry is facing regulatory changes in both the post-Brexit British and Northern Irish market and in the European Union, with new quality, health, and safety standards being introduced.
Pharmaceutical companies looking to sell medical devices on either market will have to ensure that their products adhere to the respective regulations.
Compliance with the new regulations will be mandatory by 2025, which means that changes to information leaflet sizes and artwork will be required over the next two years.
In this blog, we explore what the new regulations entail, what they mean for our customers and the solutions that we can provide.
Medical Device Regulation
A new set of quality and safety regulations have been introduced that will govern how medical devices are manufactured and distributed within the European Union.
The Medical Device Regulation will replace the outgoing Medical Devices Directive, which was in place until May 2021, and all pharmaceutical companies must be fully compliant with the new regulations by May 2024.
Some of the key aspects of the new rules include a stronger emphasis being placed on product safety, hygiene and tracking the product post-sale. This is in response to a higher propensity for medical device malfunction which has led to a greater need for transparency of technical information.
The initial regulations were introduced in a bid to synchronise any legislation relating to medical-based devices within the EU. Under the Medical Devices Directive, a manufacturer had to meet the safety and quality-based regulatory requirements to legally place a medical device on the European market.
The MDD was first introduced in 1993 but is currently in the process of being phased out and will ultimately be replaced by the Medical Device Regulation.
The MDR seeks to build upon and improve the rules included in the MDD, but the new document is significantly longer and more rigorous than the outgoing one.
In the UK, Brexit-induced regulatory changes will come into effect from New Years’ Day 2025 onwards that will impact companies looking to sell medical devices on the British and Northern Irish market.
Prior to 2020, all medical devices sold both in the UK and Europe required the CE mark which signified that a product conformed to health, safety, and environmental standards
However, from 2025 the CE mark will no longer be accepted on the majority of new products in the UK and instead a UK Conformity Assessment/UKCA mark will be required.
The UKCA mark will not be recognised in the EU market and products that require it will still need a CE mark to be sold there.
What the regulatory changes mean for Technoprint and our customers
As a result of the transition from MDD to MDR, our customers are having to include more information on their leaflets which means that we’ll be producing larger sheet sizes and making changes to the artwork.
Changes to the UKCA, meanwhile, mean our customers in the wound care production sector, will also need new artwork so that the UKCA mark can be added to their products.
The deadline for these regulatory changes to be implemented was initially this month (June 2023), but it has been extended to 2024 to give businesses more time to prepare.
Fortunately, our new printing press and folding machines, which we first put into operation at the turn of the year, allow us to provide customers with a wider range of printing solutions, including larger sheet size.
We can also help our customers with any urgent or last-minute changes they may require through our priority launch service, which will reduce the lead time.
If you think that Technoprint can provide the solutions that your business needs, then get in touch with us here to find out more.