EU’s New Cybersecurity Guidelines: Not Perfect, But Key Signposting For All Involved
How do the EU’s new cybersecurity guidelines expand on the MDR and fit into the myriad other software-related guidance documents the medtech industry has to consider?
You may also be interested in...
Lawyers Vladimir Murovec and Annabelle Bruyndonckx from Simmons & Simmons explain why the European Commission’s recently published software guidance falls short of what the EU medtech industry needs. They describe it as an afterthought and lacking legal review compared to previous MDCG guidelines.
Following hot on the heels of its Rapidly Manufactured Ventilator Specification document, the UK’s regulator has issued another speedy regulatory permit for fast production of respiratory assist devices.
The UK is taking measures to increase its ventilator stock from 8,000 to some 30,000, but it will take time to make them available. Many are asking whether the government really rejected EU help, which could have brought relief sooner, because of Brexit.