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Aspects of Regulatory Strategy


A regulatory strategy comprises 3 essential elements, Device Classification, Compliance Requirements and Compliance Ownership.


When understanding the regulatory strategy process, manufacturers need to understand the elements of the strategy.  Regulatory strategy is more than a CE mark and other compliance factors. In short, the aspects of a Regulatory strategy are:


Let’s understand in detail how these aspects form the regulatory strategy.


Device Qualification and Classification

A key challenge faced by the manufacturer is device classification (which is based on risk). After the innovation process and manufacturing of the device, regulations are often seen as a barrier for the device.  At times a wellness product may be classified as a medical device or vice versa.


Apart from this, any innovative device classified as a medical device in the USA might not be classified as a medical device in the European Union and instead considered as a cosmetic product, consumer product, pharmaceutical or a product of any other regulatory category. Be aware that devices used to administer drugs (as a drug-device combination) is regulated by a single competent authority body in the USA. In contrast, however, dual regulations are applicable in the EU.


Another common challenge is a device classified as low risk and therefore exempt from US regulation, might be considered as a medium risk classification device in the EU therefore, attracting a greater regulatory compliance regime. Particular care needs to be taken with respect to SaMD (Software as a Medical Device)


Compliance Requirements

Clinical Trials, clinical data, chemical composition etc. form the elements of compliance requirements which differ between both markets. The level of compliance data requirements might be higher in the EU as compared to the US market. Additionally, there might be a difference in economic operator requirements.


Don’t overburden yourself with this regulatory constraint. Contact us now


Compliance Ownership

Apart from the difference in the definition of the ‘manufacturer’, both US and EU require a local representative for any third country manufacturer to sell the product in the territory, the roles and duties of the EU Authorised Representative (EAR) and US agent are different.

A re-packager and re-labeller or the owner of the CE mark will be seen differently in both these markets.


These regulations should not hold back innovation. Contact our experts today and make sure your product follows and complies with all regulatory requirements.

Call: +353 (0)91-704804



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