BREXIT: MedPass can act as UK Responsible Person in the UK.

The MHRA has just announced that in the event of a no-deal Brexit all medical devices must be registered with MHRA prior to being placed on the UK market. If the manufacturer is based outside the ...

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Meet us in Dublin at the Innovation Summit 2019

This April, MedPass will be present at the annual Innovation Summit in Dublin. As a leading full services Medical Device CRO in Europe, our experts would welcome the opportunity to discuss the ...

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MedPass is ISO 13485:2016 certified !

Our Quality System is an important part of the services that we provide our clients. Therefore we are happy to announce TÜV Rheinland has certified MedPass for the latest version of ISO 13485. ...

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What happens to your Medical Devices in case of NO Brexit deal?

MedPass can help you with Medical Device Registration in the UK in case of no Brexit deal. On 4th January 2019 the MHRA (the English Competent Authority) published a guidance note, to provide ...

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EU Post-Market Clinical Follow Up: What Manufacturers Need To Know

  Interview by Amanda Maxwell The EU’s new medtech regulations introduce much more comprehensive post-market clinical follow-up requirements for device and diagnostics companies. What ...

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GDPR at MedPass International

For MedPass International, data protection and privacy is critical to our business and a priority for our organization. Our commitment to handling data meticulously and respecting privacy is core ...

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Netherlands – UDI system to be introduced from July 2018, initially for implants

The Ministry of Health, Welfare and Sport has come to a voluntary agreement with the medical device industry, hospitals and other healthcare organizations to implement a Unique Device ...

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New Regulation in the Official Journal of the EU

New Medical Device Regulation (MDR) have been published in the Official Journal of the EU on May 5, 2017 The new regulation on Medical Devices (EU) 2017/745 was published on May 5 and will take ...

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New Medical Device and In Vitro Diagnostic

New Medical Device and In Vitro Diagnostic Medical Device Regulations (MDR & IVDR) have been published in the Official Journal of the EU on May 5, 2017 The new regulation on Medical Devices ...

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A new era of data protection is beginning

“A new era of data protection is beginning. For medical device companies, compliance must begin promptly  in order to comply with the new Data Protection Regulations. The European Union’s General ...

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