Following on from the EU regulation for medical devices (MDR) that came into force over one year ago, this week I am focusing on the EU regulation for in-vitro diagnostics (IVDR).
Regulation for in-vitro diagnostics (IVDR)
In May 2022, the EU has introduced a new regulation for in-vitro diagnostics. This new IVDR included legislation to end the use of laboratory-developed tests. These tests can only be used until May 2028.
Afterwards, only industry-developed tests can be used.
Impact of IVDR
Clinicians within the BDL have criticised the IVDR. The new regulation allows less flexibility to quickly develop and conduct laboratory tests at a large scale, when there are few resources for testing.
Especially the pandemic has shown how fast laboratory-developed medicine can be introduced into routine clinical care.
Examples of this are
- the PCR tests for the SARS-CoV-2 coronavirus,
- the tracking of known virus mutations and
- the sequencing of the virus genome.
Further reading related to medical devices and diagnostics
- Happy with your knowledge on the reimbursement of medical devices in Germany?
- 8 NUB assessments of high-risk medical devices (§ 137h)
- The process of method assessments in Germany
- Will the EU regulation for medical devices result in withdrawals or shortages?
- Can the expected medical device shortages in Germany be stopped?
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