In a recent EPSCO meeting, the European Commission finally confirmed that it intends to extend the transitional period under the Medical Devices Regulation 2017/745. In parallel, the Medical Device Coordination Group has published a Position Paper (2022-18) which offers a supplemental or short-term solution, allowing manufacturers to benefit from an exemption under Article 97 for a temporary period.
On 8 July 2022, the German Health Ministry officially shared the second edition of a new bill referred to as the Act for Financial Stability of the Public Health Insurance (GKV-Finanzstabilisierungsgesetz). The bill is still subject to discussions with stakeholders and several rounds of congress hearings. If ultimately implemented, which is a likely scenario, pharma companies will face several painful cutbacks on the statutory reimbursement of prescription-only medicinal products.
Manufacturers and EU importers of medical devices are periodically confronted with new sets of rules imposing new product conformity requirements. Apart from MDR/IVDR, other EU legislation as well as revisions of ISO standards may compel companies to secure future marketability of legacy products on stock before the expiry of transition periods. To take advantage of transition mechanisms, EU legislators regularly require that affected products have to be “placed on the market” prior to a cut-off date. But what does that mean, and how should companies practically implement and record a “placing on the market”?
The Digital-Supply-Act (Digitale-Versorgung-Gesetz, “DVG”), which aims to further promote digitization in the German health care system, entered into force on 19 December 2019 and regulates, inter alia, the prescription of Digital Health Apps by HCPs (including the cost bearing by statutory health insurance). Patients insured with statutory health funds are eligible for reimbursement of Digital Health Apps. As of this August, prescription for Digital Health Apps will be available, according to statements made by the Federal Ministry of Health at an event of the Health Innovation Hub on 16th July 2020.
We will provide you with regular updates on all relevant legal developments regarding the Coronavirus disease in Germany. Please find on the link below our tenth edition of our guideline. Our team is ready to navigate you through these challenging times. Please don’t hesitate to get in contact with our…
We will provide you with regular updates on all relevant legal developments regarding the Coronavirus disease in Germany. Please find on the link below our eighth edition of our guideline. Our team is ready to navigate you through these challenging times. Please don’t hesitate to get in contact with our…
We will provide you with regular updates on all relevant legal developments regarding the Coronavirus disease in Germany. Please find on the link below our sixth edition of our guideline. Our team is ready to navigate you through these challenging times. Please don’t hesitate to get in contact with our…
We will provide you with regular updates on all relevant legal developments regarding the Coronavirus disease in Germany. Please find on the link below our sixth edition of our guideline. Our team is ready to navigate you through these challenging times. Please don’t hesitate to get in contact with our…
We will provide you with regular updates on all relevant legal developments regarding the Coronavirus disease in Germany. Please find on the link below our fourth edition of our guideline. Our team is ready to navigate you through these challenging times. Please don’t hesitate to get in contact with our…