Can the expected medical device shortages in Germany be stopped?
Serious medical device shortages in Germany have been observed – and more are expected – as a consequence of the new EU
Tag: medical devices
BfArM tightens data protection requirements for DiGAs – A new certification is needed
Since 2020, clinicians can prescribe – and SHI funds will reimburse – medical apps and digital health treatments, the so-called “DiGAs”. The BfArM assesses these DiGAs
New EU regulation for in-vitro diagnostics – the end of laboratory-developed tests?
Following on from the EU regulation for medical devices (MDR) that came into force over one year ago, this week I am
Will the EU regulation for medical devices result in withdrawals or shortages?
Hi again! This week I am switching it up a bit, and look at medical devices, particularly the EU regulation for medical
Happy with your knowledge on the reimbursement of medical devices in Germany?
Hello again, and welcome to the second post in the 3-part series on reimbursement. Last week, we focused on the reimbursement of
The G-BA increases the fees for consultations
Manufacturers of drugs or medical devices can apply for a consultation meeting with the G-BA before submitting a dossier. This consultation offers
Experience with DiGA fast track process in Germany after one year
The BfArM assesses medical apps and digital health treatments (DiGA) in terms of patient benefit, positive effects on care, data protection and
How are digital health applications assessed in Germany?
On 19 Dec 2019, the DVG came into force in Germany. This meant that since 2020, clinicians can prescribe and SHI funds
Three new methods were added to the catalogue of SHI funds
Before a new diagnostic and treatment method can be offered and reimbursed in the outpatient sector, two important steps need to be
The process of method assessments in Germany
The G-BA, physicians, hospitals, SHI funds or patient organizations can request the assessment of a new method. If the request was accepted,