Practical perspectives on medical device regulation
Insights to navigate regulation, bring medical technologies to market, and improve patient care.
EU Authorised Representative
Navigating the complexities of EU medical device regulations is crucial for manufacturers, particularly those outside the European Union.
EU Authorised Representative
Navigating the complexities of EU medical device regulations is crucial for manufacturers, particularly those outside the European Union.
Declaration of Conformity Template UK and EU
If you’re a medical device manufacturer looking to market your products in the UK or EU, preparing a Declaration of Conformity (DoC) is a critical step in the regulatory process.
Is ISO 13485 Required for CE mark?
ISO standards can be expensive. As can the certification towards them. Leading to the question, are they mandatory? We outline some of the key documents and salient points that manufacturers can use.
EU Regulation 2024/1860 and Device Shortages
As a result of EU Regulation 2024/1860, Manufacturers must inform the ANSM when the unavailability of the MDs or IVDMDs that they manufacture and/or place on the market, linked to a shortage, a risk of shortage, or a marketing stoppage, may create a risk situation in the management of the patient's state of health.
Strategy for Regulatory Compliance MDR
The Strategy for Regulatory Compliance is a requirement that has came very specifically as a result of MDR and IVDR, which begs the question, what should be the scope of the strategy for regulatory compliance?
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