Medical Device Regulations

Regulations/standards that CRFWEB 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.

Additional impacts of Medical Device Regulations: changes & additions from MDR:

Device Classification
Quality Management Systems and Technical Documentation
Product Liability
Supply Chain Regulation
Product Labelling

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 – and those expected to have completed the compliance process before 26 May 2021 can continue to be made available (or enter the market) until May 26, 2024 providing:

The device has not expired (see EU MDR Article 94.3a)
There are no significant changes (as determined by the notified body and competent authorities)

Learning more on regulatory impact

Whether pre-licence or post-market it’s important to have a thorough understanding of the MDR regulations and their global impact. Our info sheets and articles will get you up to speed in no time at all. Below you will find links to 3 useful overview pages and you can access all info sheets and articles by visiting the Medical Device Resource Centre.

Info Sheet – Medical Device Clinical Studies explained
What protocol options are available for Medical Device Studies? How are they supported by technology and what are the design considerations?
Info Sheet – Pre-market Studies
A guide to Pre-Market Studies under EU MDR.
Info Sheet – Post-market Studies
A guide to the requirements of Post-Market Clinical Follow-up studies as part of Post-Market Surveillance studies under EU MDR.

CRFWEB as part of your regulatory strategy

CRFWEB can be part of your strategy. It is a proven medical device study software application and can help facilitate a rapid turnaround of design and data entry for your medical device clinical study or program – whilst providing all the reporting outputs you need. CRFWEB will also provide a full electronic audit trail and a host of additional features to make your clinical study efficient, manageable and reportable – even when your study is performed across multiple sites in a number of countries.

Click here to read more about our technological solutions for medical device clinical trials

How can we help you meet Medical Device Regulations?

With the advent of MDR, it’s harder than ever to argue that NOT investing in EDC makes sense.

CRFweb is a full-service EDC system optimized for medical devices. CRFweb will support your journey to compliance providing a single, integrated platform for:

Clinical trial design
Data capture by site or subject
Trial process management and troubleshooting
Data management, analysis and reporting

The CRFweb software suite delivers all the key functionality you will need to ensure an MDR-compliant clinical trial in an agile, simple-to-use package optimised for the needs of medical devices at a fraction of the cost of the industry big names.

Contact us today to book your demo

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What our clients say

Maria Galligan, PMD Solutions

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

Dr Salvi, CRF Health, India

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

Nigel McLean, Cytosystems, UK

" CRFWEB eCRF, plus their helpful and accommodating staff, helped us quickly set up and personalize, with quick turn-around times of modifications, exactly what we, the clinical staff, and statistical consultants demanded, all at an affordable price "

Kelly Seamans, Atlantia

" The Clindox (CRFWEB) team are dedicated and enthusiastic about accommodating the unique requirements of each individual study and are great value for money."

Dr Satish Kumar, G7 Synergon

"Our international CRO business has utilized Clindox's integrated randomization module and Kit Management. The functionality provides everything we need, and having key trial components integrated into one system is a huge advantage to us in terms of trial efficiencies. Having both randomization and kit management capabilities, aligned with the EDC really simplifies the whole process and significantly reduces the time and effort required to manage our studies and keep control of our processes and inventory. "

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