The U.S. FDA’s pre-certification (pre-cert) program for software as a medical device (SaMD) seemed to run out of steam before the COVID-19 pandemic arrived, but the FDA was always presumed to need help from Congress to roll out a permanent version. A session at this year’s MedCon suggests that there is still life left in the pilot version of the SaMD pre-cert program, a critical development given that the legislation for the device user fee program offers the FDA no new statutory authority for a novel software regulatory framework.
In launching the European Health Data Space May 3, the European Commission (EC) heralded it as “a fundamental game-changer for the digital transformation of health care in the EU.”
Making it a done deal, the European Council adopted proposals April 12 to ensure the continued long-term supply of medicines from Great Britain to Northern Ireland and to address supply concerns in Cyprus, Ireland and Malta, which historically have been dependent on drugs from the U.K.
The biopharma industry signed on to a new pledge to increase the availability of innovative drugs across the EU and shave months from the time patients in some EU member states must wait for access to new drugs. Members of the European Federation of Pharmaceutical Industries and Associations committed to file for pricing and reimbursement in all EU countries as soon as possible and no later than two years after receiving central EU market authorization – if local systems allow it.
The European Commission has acted to thwart cybersecurity risks with a proposed cybersecurity regulation and separate proposal for information security. What is not clear, however, from these proposals is whether they would interact with existing EU rules governing cybersecurity for medical devices, raising the prospect that medical technologies will be subject duplicate oversight for cybersecurity.
The indirect impact of the Russian invasion of Ukraine on the life sciences sector continues to grow, as the West responds with more and more sanctions against Russia. In one of the latest moves, the European Commission announced March 4 that it is suspending cooperation with Russian entities in research, science and innovation.
LONDON – The European Commission (EC) has put forward proposals for a Data Act that is intended to both give users greater rights over their own data and allow greater third-party access. The Act sets out who can use and access data generated in the EU across all sectors of the economy. It is pitched by the EC as opening the doors to an under-used resource that will in turn promote research and innovation and create new markets in information services.
The EU initiated a dispute complaint with the World Trade Organization over China’s intellectual property (IP) enforcement allowing Chinese courts to block infringement litigation worldwide. The Feb. 18 complaint, posted by the WTO last week, takes issue with Chinese courts issuing global injunctions barring patent holders from asserting their rights through legal proceedings in other countries until the case is settled in China.
The EU initiated a dispute complaint with the World Trade Organization over China’s intellectual property (IP) enforcement allowing Chinese courts to block infringement litigation worldwide. The Feb. 18 complaint, posted by the WTO last week, takes issue with Chinese courts issuing global injunctions barring patent holders from asserting their rights through legal proceedings in other countries until the case is settled in China.
The guidances for in vitro diagnostics (IVDs) developed by the European Union’s Medical Device Coordination Group (MDCG) are only a reflection of the In Vitro Diagnostic Regulation (IVDR), but they do provide test developers with some important details.
