Medical devices (MDR/IVDR)

15. 2. 2023 · Publications and newsletters

New Czech rules effective December 2022 to January 2023 overhaul medical-device regulation: an amended Advertising Regulation Act eases ad rules, a new Medical Devices Act unifies MDR and IVDR implementation, and a…

28. 1. 2022 · Publications and newsletters

Regulation (EU) 2021/2282 on health technology assessment, applicable from 12 January 2025, sets up an EU Coordination Group and mandatory joint clinical assessments for new medicines and high-risk medical devices, though states…

17. 4. 2020 · Publications and newsletters

The European Parliament postponed the effective date of the EU Medical Devices Regulation (MDR) by one year to 26 May 2021 due to the COVID-19 pandemic, while the In Vitro Diagnostic Medical…

11. 2. 2019 · Articles and Interviews

From 1 January 2019, an amendment to the Czech General Health Insurance Act introduced a notification-based reimbursement system for consumer medical devices such as glucose meters and hearing aids, replacing the scheme…

1. 1. 2019 · Publications and newsletters

HAVEL & PARTNERS' January 2019 Pharma Flash reports that Act No. 282/2018 Coll., effective 1 January 2019, introduced a notification-based reimbursement system for consumer medical devices, replacing the scheme struck down by…

1. 5. 2018 · Publications and newsletters

The May 2018 issue of Pharma Flash newsletter covers recent regulatory updates on the reimbursement of medical devices in the Czech Republic.

1. 1. 2018 · Publications and newsletters

The January 2018 issue of HAVEL & PARTNERS' Pharma Flash newsletter examines the new EU medical devices regulations and their expected impact on the market ahead of the transition from the existing…