Analysing the availability of Medical Devices in 2022 in connection to the Medical Device Regulation (MDR) implementation

We are delighted to share with you the attached just-published MedTech Europe final survey report, “Analysing the availability of Medical Devices in 2022 in connection to the Medical Device Regulation (MDR) implementation”. You may also access it on the MedTech Europe website. Please feel free to share it with your members and contacts as you wish.

The 2022 Summit: for “Health”.

The 2022 Summit : For ‘Health’, the Summit will speak to the continuing impact of COVID-19 without letting the pandemic overshadow longer-term issues, such as digital platforms and investments for health systems. For ‘Development,’ the summit will explore the importance of trade, entrepreneurship, and digital innovations. Throughout the event, different sessions will foreground African voices including artists, startups, poets, authors, journalists, singers, painters, photographers, filmmakers, actors, and more, bringing diverse voices to these important issues.

Interview Dr Boitumelo Semete-Makokotlela by Herve Mwamba

Here is the full podcast episode (available on YouTube) with Hervé Mwamba and Dr Boitumelo Semete-Makokotlela, the CEO of the South African Health Products Regulatory Authority. SAHPRA’s job is to ensure that all health products (medical devices and medicines) are safe and operate the way that their manufacturers claim they operate. There is a discussion about topics such as the relationship of the regulator with industry, engagement and collaboration, alignment with already-existing systems and how to handle the pressure of leading an influential organization.

IVDR brings Huge Change to Manufacturers Distributing Products in Europe

The In Vitro Diagnostic Regulation (IVDR) means enormous upheaval for companies, as now up to 90% of products will need to be reviewed by a notified body before they are eligible for distribution in Europe under the IVDR. That’s a huge about-turn from the situation under the In Vitro Diagnostic Directive (IVDD), where approximately 80% of products were self-declared to the IVD Directive.

Covid-19 Information

In terms of the electronic communications, Posts and Broadcasting Directions issued under Regulation 10(8) of the Disaster Management Act regulation number 417 published on 26 March 2020 §514 we hereby provide a link to www.sacoronavirus.co.za for the purposes of providing READ MORE