Data integrity continues to be a focus during US FDA inspections. A number of warning letters issued by the FDA in 2022 highlight the importance of Data Integrity compliance.
In the warning letters issued, the FDA references the FDA’s guidance …
Clinical Evaluation EU-MDR requirements
This article provides a brief overview of Clinical Evaluation requirements as described in the European Medical Device Regulation – EU MDR .
What is meant by the term ‘clinical evaluation’ in the EU MDR?
The EU Medical Device …
To comply with the requirements of GMP, manufacturers must ensure that any material or service providers that they use are able to meet strict quality standards. This is due to the potential impact of materials or services on the …
The TGA recently announced an update to the Uniform Recall Procedure for Therapeutic Goods (URPTG) has been implemented, taking effect on 30 June 2022.
The URTPG:
instructs sponsors about how to efficiently and effectively remove marketed therapeutic products that pose …
Certain medical devices utilize animal materials in their manufacture to provide performance characteristics that are more advantageous than non-animal-based materials.
The use of animal material, however, carries the risk of transmitting infectious diseases when it is improperly collected, stored or …
Have you ever come away from an audit feeling unsure of your own organisational processes? Do you sometimes feel that your organisation is alone or unique in the types of audit deficiencies observed? How do you compare with others …
On 01 September 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) published new guidance on how medical devices will be regulated in the UK from 01 January 2021, following the UK departure from the European Union.
What does this …
The current COVID-19 pandemic and the measures put in place to control it is having a big impact from both a personal and a business perspective. We, as an industry, need to adapt to the current way of working …
The EU Medical Device Regulation (MDR) was the most significant regulatory change in Europe in over 20 years.
The MDR entered into force in 2017 with a three-year transition period.*
The MDR replaced the Medical Device Directive 93/42/EEC and …
SaMD: A need for Regulatory Reform in Australia
In February 2019, the TGA issued a consultation for feedback from industry on how Software as a Medical Device (SaMD) is regulated in Australia. Currently, SaMD is regulated under the existing medical …
