Gain confidence, reassurance and control over your EU MDR strategy

Dr Gayle Buchel
A woman writing her own medical device regulation documentation

What if there was a way to save a portion of your regulatory budget by writing your own MDR technical documents? What if you could build your own technical file using proven frameworks and detailed templates, with step-by-step guidance from EU MDR experts?

EnableCE from Mantra Systems is a product suite created for medical device manufacturers who would like to take control of their own regulatory processes but are in need of training, support or guidance from regulatory specialists.

By building your own technical files within a guided framework, unnecessary financial outlays for comprehensive regulatory consulting packages can be minimised.

The cost of compliance

With increasing costs across the industry, the requirements to become EU MDR compliant can add significant expense to an already tight balance sheet. Afterall, transitioning to the MDR is costly — MedTech Europe estimates compliance costs of 8-15% of revenue from certified devices, which translates into £800K - £1.5M for an SME with revenues of £10M.

In the MedTech Europe report (commissioned by Innovate UK in September 2019), the readiness of UK small and medium size enterprise (SME) medical device companies for the Regulation (EU) 2017/745, commonly referred to as the EU Medical Device Regulation (MDR), was investigated.

In response to the survey, with less than one year to go to the date of application of the MDR, 60% of medical device manufacturers had not yet budgeted for the MDR. Of the 40% who had, only 12% had provisioned between 8-15% of their impacted sales revenues.

Regardless of the device classification, EU MDR compliance is a labour-intensive and expensive exercise. It requires significantly more in terms of clinical evidence, risk assessments, post market surveillance, supply chain obligations and data for the Unique Device Identification (UDI) system and the new EU Eudamed database.

EnableCE – saving you time and money

EnableCE was built to give the control of timelines and regulatory budgets back to the medical device manufacturer. Regardless of the degree of assistance you require, there is an EnableCE product for everyone.

Mantra Systems is well positioned to be your regulatory partner for Clinical Evaluation, guiding and supporting you while you complete your own MDR compliant technical file.

Please contact us if you have any questions about this article or would like to discuss our products and services in more detail.

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