The amount of regulation and legislation coming into the life science space has never been higher. Ashley Goldie of artwork management firm Kallik explains why labeling will be directly in the firing line – and why a new approach to managing the process will be required
The life science sector is used to coping with regulation. But it’s about to face a deluge of compliance change. Here’s a brief summary of the ones that will be impact you, perhaps sooner than you think:
Premarket Notification (510(k)) submissions for medical devices now need to take into account the full product lifecycle[1]. The Unique Device Identification (UDI) system being introduced by the US Food and Drug Administration (FDA)[2] comes into force in the US this September, with Europe to follow within the next 2-3 years – then China and the rest of the world. Companies targeting the US market will need to submit device information to the new global UDI database (GUDID)[3]. Vendors must include UDI information on all device labelling and packaging, provide a UDI in both plain-text and automatic identification and data capture (AIDC) formats[4] and include UDI information on any device intended for multiple uses or requiring reprocessing after each use. Note that for the most invasive products, the deadline for compliance is bearing down hard, with compliance expected within nine months.
In Europe meanwhile, in September 2013, the European Commission announced two new measures to improve the safety of medical devices so as to “restore patient confidence in the medical devices sector” following events such as the PIP breast implants scandal[5].
Some 10,000 types of products may be affected by all this – from sticking plasters to the latest generation of pacemakers.
That’s not all: it is now required that notified bodies randomly perform unannounced factory audits and check adequate samples from the production. Meanwhile, Brussels is also looking for clearer labelling, down to the individual product level: the goal, as in the US, is to increase device traceability along the supply chain. Plus the Commission has already told the market it will not be sufficient to demonstrate that all devices are correctly classified – technical documentation must be ‘complete’, is its somewhat opaque directive here.
Why data is vital
The bottom line here is that you need to have a robust, transparent process in place to deal with these, and any other potential, compliance challenges.
That means investment. But there is also an opportunity here, if you use the new requirements to drive deeper changes to the way you manage your labelling activities.
However, putting in ‘point’ solutions that keep the regulators happy may tick a box. But it will not deliver additional benefits to the business beyond meeting the immediate crisis.
Instead, a truly effective system should not simply be about delivering compliance, but ensuring that an organisation can prove that compliance, and in a way that does not have a detrimental impact on other business processes.
And why tech is your friend here
Technology has a huge contribution to make in helping to organise and automate the way data is collected and managed to deal with all these challenges.
For example, our pharma customers report that a content-centric approach to working with labelling, as opposed to a document-based one, can be a huge time-saver. That’s because their systems will only ever have one instance of, for example, a usage statement, which it will then automatically track across all iterations, so that you never duplicate or corrupt content. For Jette Byg at Danish-headquartered Coloplast that supplies specialist medical products, “Kallik has brought a completely different perspective to the way we manage our content management activities. Previously, every change meant starting from scratch and could take months to implement, requiring approvals of local translations from 30-40 countries. Because changes happen all the time in our dynamic market, this meant we were never in compliance – we were always behind.”
This integrated, holistic approach could be a huge boon as you deal with the new legislation coming your way – as well as the consolidation, globalisation and other changes that you need to be on top of in the next few months and years.
[1] http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketnotification510k/ucm070201.htm
[2] http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm?utm_source=Members-Only+Updates&utm_campaign=c7c1e8c870-Proposed_Rules_7_5_2012&utm_medium=email
[3] http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/GlobalUDIDatabaseGUDID/default.htm
[4] http://www.aidc.org
[5] http://ec.europa.eu/health/medical-devices/documents/revision/index_en.htm. The associated regulations are 920/2013 on the designation and the supervision of Notified Bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices, plus Commission Recommendation on the audits and assessments performed by Notified Bodies in the field of medical devices 2013/473/EU