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The New Regulatory World for Medical Devices

Establishing an Effective Compliance Strategy Now Ahead of the 2022 IVDR legislation – Because There’s More to Come

No sooner than medical device manufacturers have completed their MDR compliance project, they must prepare to adapt products, labelling and artwork to comply with upcoming IVDR counterpart legislation. Set for implementation in May 2022 and to be followed by more waves in 2023, 2025 and 2027, IVDR will require many businesses to begin the compliance cycle from the start again, to ensure they can continue to sell in vitro diagnostic products into the lucrative EU market. Many of these challenges will mirror MDR efforts – with lessons to be learned and technological innovations ready to ease the process. Bob Tilling at Kallik describes the top compliance challenges manufacturers must address – and how digital platforms can support ongoing compliance efforts.


‘The New Regulatory World for Medical Devices’

Here are the top compliance challenges manufacturers must address – and how digital platforms can support ongoing compliance efforts.

The EU’s In Vitro Diagnostic Regulation is set to be implemented in May 2022, but for many in vitro medical device manufacturers, the follow-on UDI implementation deadlines – Class D in 2023, Class C and B in 2025, and Class A in 2027 – will have greater repercussions. Over 80% of devices not requiring certification under the previous IVDD (In Vitro Diagnostic Directive) will now require IVDR certification, affecting quality management, traceability, packaging and beyond. Product labelling and artwork for these devices will need to be adjusted accordingly.

IVDR compliance is simply non-negotiable – and as many manufacturers found during the MDR deadline rush, it cannot be left until the last minute. Failure to comply can bring catastrophic damage to a business, ranging from financial pressures and end-to-end operational disruption through to irreversible damage to consumer confidence and brand reputation.

Early Action Solves Many Pain-points

A key lesson learned by many medical device manufacturers during their recent MDR compliance projects was the need to get started with planning and execution at the earliest possible stage. Companies that chose to ‘go it alone’ and push ahead with manual processes, legacy in-house systems and no external compliance expertise often struggled as the scale and complexity of the task became apparent.

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