The European medical device industry is in the grip of the biggest change the market has seen in decades. Significant new rules to ensure the safety of medical devices became active in June 2017, imposing heavy requirements on anybody involved in the design, manufacture, approval and commercialisation of devices that are sold in the EU.
The European Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR) ensure high standards of quality and safety for medical devices being produced in or supplied into Europe.
The size of the organisation does not matter; the EU MDR does not draw distinctions. So, whether you are a large company or an SME organisation, you have to comply as well as prepare for future regulations. PRISYM ID has put together these 10 steps to assist you with the implementation of EU MDR labelling.
Gap analysis and risks
Under EU MDR, the entire product lifecycle is subject to new and comprehensive scrutiny. Its scope demands medical device organisations (and their external partners) to review processes and systems that touch every aspect of their operations. The consequences for labelling operations are particularly significant, highlighting an organisation’s ability to capture, manage and share data across its entire enterprise.
The first step to compliance is to perform a gap analysis and understand where issues may arise and the risk your company is exposed to.
Raise awareness
You must make sure that decision makers and key stakeholders within your organisation are aware that the regulations are changing. Get them engaged and set a clear path and timeline. Implementing EU MDR will have a significant impact on resource regardless of the size of your organisation. You’re in control, so make everyone aware of the timeline and changes; no one likes a last-minute surprise.
Importance
When planning for EU MDR, you not only need to think about how to gain approval, but also how to maintain it. A key component of EU MDR will be labelling processes and systems. With the intent of improving product safety, offering increased visibility and further standardising industry regulation, this is a chance (if done right) to give your organisation competitive advantage.
Mark Cusworth, VP Research and Development, PRISYM ID
Timeline
The timeline for EU MDR’s regulatory framework requirements is available; make sure your leadership team and staff are aware. The first major milestone of the adoption timetable was the introduction of the new European Database for Medical Devices (EUDAMED), which went live in December 2018.
This development alone is the catalyst for a wave of labelling challenges that could prevent businesses from being able to sell their devices in Europe if they are not addressed in time. To register products successfully, companies must comply with new and specific requirements around labelling content.
Team knowledge
Whether your team is small or large, a strong multidisciplinary approach is required to implement the organisational changes necessary to become EU MDR compliant. Knowledge is key; make sure you leverage both in-house and third-party expertise.
Define your strategy
Strategy and planning must start now; there is no more time to waste. You must be certain that your existing labelling systems and procedures can cope; if not, you need a strategy to update, upgrade and/or streamline.
Operations and supply chain impact
The revised labelling requirements will introduce much complexity to labels, packs and packaging — presenting a major impact on operations and the medical device supply chain in Europe. Highlights of these requirements include the following: the label must state that “This is a medical device” and include the EU Authorised Representative and Address; the label must have the ability to process and sustain an audit; implant cards must hold lay friendly and language-specific information allowing identification of the device, including UDI, any follow-up, warning, precautions or measures; the label must include specific instructions for use (IFU) and enable supply chain traceability and reporting.
Capabilities and systems
Make sure you research, understand and implement an overarching infrastructure of the entire labelling solution, grasping its challenges and opportunities. Many organisations favour old in-house or legacy systems for fear of change.
But with the new legislation and content changes (with the need to be revise, approve and release at the correct time and include the correct labels/artwork), these outdated labelling systems and processes may not cut it, running the risk of non-compliance. Recognise that, fundamentally, it’s not about the label, it’s all about the underlying data — and for that you need the right technology.
EU UDI marking adoption
The EU Commission has clearly defined the requirements for the execution of UDI for MDR and IVDR, with little differentiation other than the implementation timeline. As UDI wasn’t a prerequisite of MDD, this is entirely new for the European market and imposes new requirements on all involved — from manufacturers right through to healthcare professionals. So, unless you’ve been manufacturing/trading with the US and the FDA’s regulations, it’s now time to understand its impact on your business.
Be ready for audits
After all this, are you compliant? Make sure you establish monitoring and reporting frameworks so that you are ready for unannounced audits. Regardless of the size of your business, you will need to audit your packaging artwork and labelling to ensure that they meet the new requirements and update them accordingly if they don’t. The new requirements may span your whole quality system.
The importance of selecting a labelling solution that can adapt to a changing world cannot be overstated. It needs to be compliant with EU MDR by 2020. However, do not lose sight that Microsoft and Oracle are ending their support for several operating systems and databases by 2020/23. Crucially, ensure that you only touch your labels once while, at the same time, addressing both impending deadlines safely and effectively.
NB: This article will appear in the March 2019 issue of Manufacturing Chemist. A recent digital edition is available online.
