IVDs, for the first time, are coming under strict regulation in the EU. Moving on from Medical Device Directive 98/79/EC and Commission Decision 2010/227/EU, the European Commission announced the introduction of Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices.
Due to the pandemic, these Regulations are now fully enforcible and will be in place starting 26th May 2022.
Medical devices and In Vitro Diagnostic medical devices (IVDs) have a fundamental role in saving lives by providing innovative healthcare solutions for the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease.
It is important to ensure that these devices and diagnostics are safe for all parties. The regulations enforce the end-user’s safety by assuring that the manufacturers follow the right practices.
Many uncertainties and confusions regarding the regulations have been pestering the market. To clear all your doubts, we are coming up with an IVDR Masterclass on Tuesday 29th March 2022 from 1:00 PM – 3:00 PM delivered via ZOOM. [Recording available on YouTube].
This masterclass will suit anyone interested in knowing
- The Overview of In-Vitro Diagnostic Regulations
- Key Changes and introduction of different roles in the MedTech Ecosystem
- Importance of IVDR for Digital Health Diagnostic manufacturers
- Regulatory requirements for SaMD under IVDR
Please click on this link to register for the session – Register NOW!
Our team will be in touch with the meeting details.
Please feel free to connect with us at any time by sending an email at firstname.lastname@example.org
Don’t Let Regulations Hold Back your Innovation!
Speakers of the Session
Jay R. Shah - Communications Officer - Med-Di-Dia
is a #GENZ in MedTech space who creates innovative content around MedTech Regulations and will be the Session Moderator for this Masterclass.
Greer Deal – Co–Founder - Global Regulatory Services Ltd
A Fellow of the Chartered Management Institute and a member of The Organisation for Professionals in Regulatory Affairs (TOPRA), Greer has over 30 years’ experience in the life science sector. In 2007 she co-founded an independent consultancy, Global Regulatory Services (GRS), with a focus on regulatory affairs and quality compliance. She is frequently asked to speak at seminars on a wide variety of topics and increasingly on the changing regulatory scene for Medical Device companies in the UK and Europe. She is passionate about regulatory affairs being recognised as an asset which adds value to a company’s bottom line and ensures only good quality, safe products enter the market.
Lucy Campbell - Entrepreneurship and Marketing Lead - EIT Health
is a communications, marketing and business transformation leader with significant experience in media and academic institutions. She has focused on working within organisations on growth strategy and commercialisation, bringing new products and services to market. In her role with EIT Health Lucy is connecting health start-ups and innovators to the wider European Health innovation network to accelerate their businesses through access to education and training, stakeholders and investors.
David Didsbury – Associate Consultant – Med-Di-Dia Ltd
David has over 40 years of experience in the medical device industry, a degree in Biomedical Electronics and an MBA in Technology Management. He has held multiple roles in SMEs and multinationals, with significant experience and expertise in international medical device regulations and quality requirements. He has helped SMEs successfully introduce FDA/ ISO 13485 compliant systems, including Design & Development processes (IEC 60601 and IEC 62304, firmware, PC, cloud and mobile apps.).
Paul Butcher - Associate Consultant - Global Regulatory Services Ltd
Paul brings over 35 years of computing experience gained across a number of industries including Engineering, Banking, and Finance Data Management, where he has designed and delivered secure computer infrastructure solutions for both physical and Cloud based virtual systems. For the last four years he has been using a more data-focused approach to Cybersecurity and Vulnerability Scanning. All of his Cybersecurity, Information Management and Design skills have easily transferred over to help implement secure systems and IoMT, now in the medical device industry.