March 24, 2023

EU Commission Publishes Q&A on the MDR Transition Extension

Now that the MDR transition period has been formally extended, the EU Commission released a Q&A document on the ‘practical aspects’. Click to read the update.
March 23, 2023

New EU Commission Proposal: “Master UDI-DI” for “highly individualised devices”

The EU Commission has proposed a new term and principle (‘Master UDI-DI’) for certain types of medical devices. What does this mean and how does it impact you?
March 20, 2023

MDR Extension Published, Enters into Force Today

March 10, 2023

MDCG: 2023 Guidance Documents in Development

The Medical Device Coordination Group (MDCG) published a (non-exhaustive) list of guidance documents in development for 2023. Click to find out what to expect.
March 7, 2023

EU Council Adopts MDR Extension: What’s Next?

Today the EU Council adopted the Commission’s proposal. What are the next steps and when is the MDR extension expected to be implemented?
February 16, 2023

EU Parliament votes “yes” to the MDR Postponement

Today EU Parliament voted in favor to amend the MDR Article 120 transition provisions, in its first reading. What does this mean, and what are the next steps?
February 14, 2023

MDCG 2023-3: Q&A on MDR Vigilance Terms and Concepts

New MDCG guidance was issued on MDR vigilance terms & concepts. Find out the key takeaways, including when the reporting 'clock' starts, examples and more.
January 31, 2023

EU Council Accepts Proposal to Postpone MDR Deadline

The EU Council has officially accepted the proposal, with no changes. What does this mean in terms of timing to implement the new deadlines for MDR compliance?
January 12, 2023

MDCG 2023-2: Guidance on Publishing Notified Body Fees

The MDCG published a guidance document on Notified Body fee transparency, including a table of how fees could be presented to the public. Read more here.