The medical device industry, one of the most heavily regulated industries, was greatly impacted when the UK withdrew from the European Union in 2016. This has resulted in confusion for medical device manufacturers who must ensure compliance with UK MDR (Medical Device Regulation) and EU MDR. This blog post aims to explain the critical differences …
If you are a medical device manufacturer who wants to legally CE your products in Europe, then you must ensure you comply with the appropriate medical device directive or regulation as set out by the EU Commission. Understanding the EU MDR classification system In Europe, there is a rule-based classification scheme for medical devices. Medical …
EU MDR Device Classifications: What You Need to Know to Ensure Compliance Read More »
Stay compliant with EU Reg. 2023/607. Expert guidance from Shiro Business Solutions – UK’s top medical device regulatory consultancy
The MHRA announced a one year delay for UKCA Marking and confirmed a 3 to 5 year transition period for CE Marked devices this week.
The MHRA announced a one year delay for UKCA Marking and confirmed a 3 to 5 year transition period for CE Marked devices this week.
Shiro Business Solutions offers information on the UKCA marking required for medical devices sold on the market in Great Britain (GB).
The deadline for appointing a Swiss Authorised Representative (CH-REP) for Class 1 Devices, and System/Procedure Packs is fast approaching.
The Medicines & Healthcare products Regulatory Agency (MHRA) has been responsible for medical device and pharmaceutical regulations in the United Kingdom since 2003
The United Kingdom Conformity Assessed (UKCA) mark is replacing the CE mark in Great Britain, as the United Kingdom left the EU single market on 31 December 2020.
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