Tim Congdon, European Business Development Manager at brand protection and security technology experts CCL Design UK spells out the implications of not getting your regulatory ducks in a row

Although uncertainty remains over whether the UK and Brussels will reach a Brexit deal, medical device manufacturers must not delay in turning their attentions towards addressing some of the industry’s regulatory matters – as deal or no deal – compliance is necessary.

One such area is the new EU Medical Device Regulation (MDR) and the EU In vitro Diagnostics Regulation – where medical device manufacturers and the businesses involved in there supply chains now only have 18 months to comply in full to the former (26^th May 2020) and under four years to comply with latter (26^th May 2022).

Legal experts advise that manufacturers should not assume that Brexit will mean that they won’t need to comply to these new EU laws as regulatory alignment between the UK and the EU in respect of these medical regulatory matters is likely to continue. For instance, the recently published Withdrawal Agreement provided details of a transition or implementation period starting from the UK’s exit from the EU on 29 March 2019 and ending on 31 December 2020. During that period, all EU rules and regulations will continue to apply in the UK, and the EU MDR will be fully applied from May 2020 (during this implementation period).

Why do we have new regulations?

We need to look no further than the ‘PIP’ breast implants and DePuy metal hip replacement scandals for evidence of why new regulations needed to be introduced, as both these events highlighted weaknesses in today’s legislation. So, these new regulations, introduced by The European Commission, aim to improve the quality, safety, and reliability of medical devices, while also strengthening the transparency of information for consumers and enhancing the vigilance and market surveillance.

A lack of understanding

Despite awareness to the new regulations being relatively high, most manufacturers are uncertain of how far reaching the regulations will be. A survey published earlier this month by KPMG and the Regulatory Affairs Professionals Society (RAPS) found that four-fifths of regulatory and quality leaders at medical device companies lack understanding of the EU MDR and the difficulty of understanding the requirements was revealed as the biggest barrier to compliance.

This comes as no surprise, as the EU MDR is far reaching and more prescriptive than previous regulations. For instance, one of the major changes is how it defines a ‘medical device’ – with software now included and products previously considered accessories to those devices such as cleaning and disinfecting products also included. The regulations also encompass products without an intended medical purpose such as contact lenses, dermal or other fillers, and equipment for liposuction to name but a few.

The first steps to compliance

A good starting point is for medical device manufacturers to identify the differences between the EU Medical Devices Directive (MDD) and EU MDR. Next, the management team needs to recognise that compliance will take time and it may require a dedicated team – handpicked from different parts of the business.

This team should be first tasked with reviewing product portfolios to understand which products need to comply.

As each device will now need to have a unique device identifier (UDI) placed on the label and/or package of medical devices, these products will not only need to be tracked by manufacturers, they will also need to be tracked by authorised representatives, importers, and distributors. The dedicated team should therefore identify all of the actors in the supply chains that the business will need to collaborate with to fully comply. And, with more actors taking responsibility in the supply chain, it is very likely that all these parties will need modify their quality management system to ensure information is not lost but stored in a proper, systematic way.

However, tracking will be made easier, as the UDI will now need to be logged on the European database for medical devices (EUDAMED), and the records will be updated to give a living picture of devices as they move through the supply chain, which will help detect and reduce counterfeiting.

Tim Congdon

The path to compliant labelling and traceability

When it comes to ensuring the product labelling is compliant, one of the key challenges is the amount of information that must now be included on the label or package. The UDI produced for a device comprises an UDI-DI (device identifier – specific to a manufacturer and device) and an UDI-PI (production identifier – identifies unit of device production).

At the same time, medical device manufacturers will also need to decide whether they require printed products direct for their application, or digital printing systems developed so they can print on demand. Critically, providing the best solution that fits the requirements can be split into the following two elements:

1. Determining the right base material to provide the carrier of information requires durable flexible substrates that retain the information under stringent environmental testing. It is also necessary to combine the substrate with specialised adhesives to ensure the information is adhered to the product for its lifetime which may include washing cycles, high temperatures, and humidity. This must take into account the composition of the material it is being applied to, the surface texture, and surface energy.
2. The second consideration is how the information is printed. This needs to be compatible with the label substrate to ensure it provides a high-quality print that is durable and readable both electronically and by eye. By developing specialised topcoats, CCL have been able to provide a wide range of materials and printing systems that meet the harshest environments a product can be subjected to.

Absolute compliance is critical

Finally, don’t think that the regulator won’t come knocking. The regulatory notes also cite that there will be enhanced market and post-market surveillance, with regulatory authorities having more rights to conduct audits, including unannounced visits. At the same time. manufacturers (or their authorised representatives) will need to have at least one person responsible for regulatory compliance, either within the organisation or as an available consultant.