Introduction In today's globalised marketplace, manufacturers seeking to enter the European Union (EU) market must navigate a complex regulatory landscape. One of the most crucial requirements is obtaining the esteemed CE Marking...

The Evolving Regulatory Landscape The Medical Device Regulation (MDR) (Regulation (EU) 2017/745) came into full effect in May 2021, replacing the previous Medical Devices Directive (MDD). The MDR introduces stricter requirements than...

Understanding the Regulatory Landscape The EU regulatory landscape for medical devices is dynamic and constantly evolving. Consultants must stay current with the latest regulations, including amendments and interpretations. Key aspects to grasp...

Understanding CE Marking CE stands for Conformité Européenne, which translates from French to "European Conformity". It's a marking that signifies a product's compliance with various safety, health, and environmental protection standards set...

What is CE Marking? CE stands for "Conformité Européenne," which is the French term for European conformance. All 27 EU members, as well as Iceland, Norway, and Liechtenstein, must have the mark...

Post-Market Surveillance (PMS) is a regulatory requirement. It is mandatory in global markets including the United States and European Union. PMS comprises of activities that relies on data gathering. It helps collect...

After separating itself from the European Union, Great Britain introduced UKCA Mark mandatory for medical devices to conform to the new regulations. Any manufacturer who wishes to enter into the UK market...

Any manufacturer who intends to market their medical devices, including in-vitro diagnostics in the UK, must register medical devices with the Medicines and Healthcare Products Regulatory Agency (MHRA) before placing them into...