E-labelling regulations play catch-up

The EU has put the use of new technologies at the forefront of its eHealth Action Plan digital strategy. However, its own regulations make it enormously challenging for manufacturers to bring one key aspect of medical devices development into the 21st century: e-labelling.

Medical device manufacturers spend millions of pounds of their product budgets on meeting regulatory conditions in terms of documentation and supplier manuals. Electronic labelling – or e-labelling – was seen as a revolutionary way of cutting print and distribution costs by moving manuals online or into embedded software.

While the savings may be there in terms of hard copy logistics – as well as the environment – the regulatory framework has meant the move to e-labelling has been significantly more challenging than manufacturers would have liked.

The regulations on electronic instructions for use of medical devices (No 207/2012 of 9 March 2012) came into effect in March 2013.

They place considerable limitations on the range of devices that can be e-labelled – most significantly, the regulations only permit equipment to be e-labelled if it is a fixed asset and used exclusively by medical professionals; devices used by patients are excluded.

“Currently, in Europe, manufacturers can use e-labelling for devices that are for professional use only – for example, an X-ray machine or CAT scanner. However, as soon as certain information needs to be provided to the patients, e-labelling can’t be used,” says Holger Most, regulatory affairs manager EMEA at GE Healthcare Information Technologies.

Many devices that could benefit from e-labelling under a more relaxed regulatory framework are excluded from the regulations. Given that the regulations only permit ‘fixed installed devices’, there are also grey areas, such as fixed installed X-ray machines and CT scanners becoming mobile devices.

The availability and affordability of portable devices is one just one area where the pace of new technologies has outstripped the regulations governing them.

Most explains that there is a gap between the technologies covered in the e-labelling regulation and the recent technological developments in this sector.

“Many of the challenges with the regulations – at least as far as manufacturers are concerned – are due to the technological developments moving at a faster pace than the regulatory processes,” he says.

When the regulatory wheels started turning, the pace of change in the electronics sector could scarcely have been imagined.

“Regulations take several years to develop. In this context, one has to remember that the first iPhone was put on the market in 2007 – that’s ten years ago. When the first developments for the e-labelling regulations began in 2002, there was no app store – there was nothing like it. This technological progress was not foreseen and therefore could not be taken into consideration during the development of the e-labelling regulations.

“Today, in the app stores, many medical apps can be found. However, according to the law, most of these apps cannot be e-labelled because they are intended for non-professional use.”

Aside from the ease of access, e-labelling offers presentation benefits in terms of the use of illustrations and images to better explain information.

“If the user could always have access to the instructions on their medical apps, it would be beneficial for the safe use of the medical device. Just imagine a user having ten medical apps on their smartphone – it is very unlikely that somebody would always be carrying these ten instruction manuals (in paper format). That just doesn’t happen.”

Conforming to the regulations

There are other aspects of the regulations, too, that can provide logistical challenges for manufacturers.

There is an obligation for manufacturers to conduct a documented risk assessment covering the knowledge and experience of the intended users, and the operating environment for the device in order to use the e-labelled devices safely. However, there is no obligation for the hospital to inform the manufacturer when any of the evaluated conditions change.

Other safeguards include a guideline for manufacturers to provide a paper version within 14 days on demand.

“In terms of requirements, there is no major difference between e-documents and paper manuals,” says Most. “Manufacturers have to ensure that the caregivers – the doctors, nurses or whoever is using the medical device – have all the information they need to use the product in a safe way.

“All requirements present for paper documents must be met by electronic documents as well. So, for example, language requirements (such as translations) are the same for paper as they are for e-documents.

“The regulation requires that the instructions for use in electronic form shall contain at least the same information as the instructions for use in paper form. Obviously, if the scientific knowledge changes, manuals need to be updated and distributed to all users – safety is paramount.”

While there are printing, logistics and distribution cost benefits for e-labelling, it isn’t without its own distribution challenges.

“When manufacturers distribute the documents electronically, they need to ensure that these documents are received. When offering a download via an internet portal, manufacturers need to provide the various document formats and translations for all versions of their products. The manufacturer needs to track all of these activities, which can be challenging when considering the data-privacy requirements.

“With software from an app store, an update of the user manual is potentially easier because manufacturers can push updates to their customers via the respective app stores.

“For some devices, especially when being serviced by the manufacturer, embedding the manuals in the device makes it easier to track which version of the manual is installed – and in what language – for each customer. However, based on the current regulations, paper manuals must be provided to the users on demand.

“In the current e-labelling regulation, there are several requirements that can’t be met by some of the currently available devices. For example, does the regulation require a sticker to be affixed to the product advising the users of the location of the instruction for use? However, with non-tangible devices like medical device software, this would not be possible.”

In such a fast-developing industry, Most says it will always be a challenge for regulators to keep up with current developments.

“I can’t envision how to achieve regulations that are in line with the most recent developments. Maybe the e-labelling regulations should follow a new approach, such as the approach being used by the medical device directive, which defines a set of minimum safety requirements that all products need to meet. Additionally, regulators might want to focus more on the post-marketing aspects in order to identify specific trends or issues with, for example, e-labelling on the community market.

“It’s hard to imagine what technological developments we will have in ten years. What I do know is that, with digital applications, developments are going to be huge. Think about current developments in deep learning or artificial intelligence. Currently, these technologies are barely covered in the existing regulations.”

Regardless of the logistical advantage, Most says e-labelling is commonly accepted. “In my experience, since the e-labelling directive was put into place, fewer than 2% of the customers require paper versions. This might be due to the products we have and it might not be true for other manufacturers – they need to look at their customer’s needs. From a commercial side, if customers dislike e-documents, then manufacturers would need to provide paper documents.

“Every manufacturer needs to review the regulations and determine how to apply them for their products in order to develop a compliant and manageable e-labelling framework.”

The future of e-labelling

Most says the developing markets in particular have been slower in creating medical device regulations and e-labelling requirements. Some African countries are starting to put in place regulatory guidelines for e-labelling, but progress is slow.

“We are starting to see more regulations being developed. These show similarities with current existing regulations in the EU and US; however, each country will have its own spin on the details of the requirements. In Nigeria, for example, medical device regulations exist, but no specific e-labelling regulation for medical devices. Manufacturers will need to review the requirements of every single country in order to be successful in that particular market.”

“Currently, I don’t see specific e-labelling requirements for the African markets. What I see is that countries are developing medical device regulations to ensure that only safe medical devices are being placed on their market.”

Devices approved for e-labelling

Devices must be for the exclusive use of professionals and fall into one of the following categories:

1. Active implantable medical devices and their accessories covered by Directive 90/385/EEC intended to be used exclusively for the implantation or programming of a defined active implantable medical device
2. Implantable medical devices and their accessories covered by Directive 93/42/EEC intended to be used exclusively for the implantation of a defined implantable medical device
3. FIxed installed medical devices covered by Directive 93/42/EEC
4. Medical devices and their accessories covered by Directives 90/385/EEC and 93/42/EEC fitted with a built-in system visually displaying the instructions for use
5. Stand-alone software covered by Directive 93/42/EEC.

Source: Commission Regulation (EU) No. 207/2012 of 9 March 2012 on electronic instructions for use of medical devices.