Medical Device Regulations

Regulations/standards that Clindox can help you meet:

FDA (CDRH) 21CFR 807 and 814, GDPR, HIPAA, MEDDEV and the transition to IMDR and IVDR

The global Regulation Situation

Medical Device Regulations. The reality in today's global market is that any medical device producer needs to be aware of what is potentially a plethora of regulations for their intended market(s). Organisations are naturally well-versed in the different device classifications used in the US and the EU but are having to come to terms with the fact that the changes in world regulation means a strategy is required for any organisation wishing to sell their product globally.

There are many compliance considerations but key for many are the MDR regulations... whether you're EU-based or not, if you wish to sell in the EU you need an EU licenced device and you need to maintain that licence with annual records to demonstrate the efficacy and safety of your product. It's not just Europe, legislation that tightens regulatory requirements is being brought in across the globe, for example IMDR in India.

EU MDR Regulation Summary

The European Union's Medical Device Regulation ((EU)2017/745), known as "MDR", has been operative since 26th May 2021. The introduction to the legislation states:

"(4) Key elements of the existing regulatory approach, such as the supervision of notified bodies, conformity assessment procedures, clinical investigations and clinical evaluation, vigilance and market surveillance should be significantly reinforced, whilst provisions ensuring transparency and traceability regarding medical devices should be introduced, to improve health and safety."

Devices already on the market under the Directives 90/385/EEC and 93/42/EEC can continue to be available providing the device has not expired and there are no significant changes.

Clindox as part of your regulatory strategy

Clindox is a proven medical device study software application that facilitates rapid turnaround of design and data entry for your clinical program. We provide a full electronic audit trail and a host of features to make your study efficient, manageable, and reportable.

What Our Clients Say

"The Clindox team have been an incredible support and are always available to help in any way they can."

MARIA GALLIGAN, PMD SOLUTIONS

"The time and cost saving is really significant. We're very happy with the performance of Clindox and I wouldn't hesitate to recommend it."

DR SALVI, CRF HEALTH, INDIA

"Clindox eCRF, plus their helpful and accommodating staff, helped us quickly set up and personalize exactly what we and the clinical staff demanded."

NIGEL MCLEAN, CYTOSYSTEMS, UK

"The Clindox team are dedicated and enthusiastic about accommodating the unique requirements of each individual study."

KELLY SEAMANS, ATLANTIA

Next Steps

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