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Common pitfalls during the CE marking of a Medical Device or IVD

A CE (Conformitè Europenne) Mark is mandatory for medical devices manufactured, designed, marketed, and supplied within the European Economic Area (EEA) & European Union (EU). The CE Mark is a representation of the manufacturer’s declaration that the product complies with the EU’s applicable directives/regulations. Compared to the MDD & IVDD, the current MDR 2017/745 &…

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Quality — The key to customer satisfaction

Quality in a service or a product is not what you put into it; it’s what the end user gets out of it. In healthcare, the term “quality” has a lot of importance as it helps to achieve greater consistency in activities that are involved in the development of products and services. It increases efficiency…

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How do IVDs differ from LDTs? Confused? Here’s the key

Diagnostic laboratories in today’s world face a slew of issues; from managing complicated test panels to handling ever-increasing sample quantities. In order to overcome such problems, busy laboratories discover new methods to expand. They make themselves flexible, necessary enough, to keep up with the proliferation of pathogens. Knowing the regulatory environment is crucial for the…

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A to Z of a Clinical Evaluation Report

One of the most integral parts of getting regulatory approval in the European Union (EU) is a Clinical Evaluation Report (CER) that demonstrates the safety, performance, and efficacy of your device. What is a CER? CER is a report of the assessment and analysis of a medical device’s clinical data which is typically collected to…

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EU Classifications and Rules for CE Marking

For the manufacturers trying to figure out ways to place their medical devices in the EU market, classifying their devices based on their intended purpose should always be the first step.  As per the EU regulations, the classification is based on the risks involved in the device. It is very important to classify your device…

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Is your product Misbranded?

Misbranding is a serious issue in the healthcare industry. For all the claims, indications for use, and other labeling details accompanying the product there must be some supporting data on file to avoid misbranding of your device. Misbranding can result in inadvertent misuse and potential adverse events.  Example of misbranding An example of this is…

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Ways to Report Medical Device Incidents in Australia via the MDIR System

Stop worrying about enforcing a safety culture! A safety culture can be built by constantly making people aware of reporting regulations and requirements based on the countries in which you are selling your medical devices.  If your medical device is currently sold in Australia the prompt Incident Reporting of Medical Devices by the Australian TGA…

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The US FDA Medical Device User Fee for the Fiscal Year 2022

What do the applicants of 510(k) or other regulatory applications or companies looking to register or import need to pay? The FDA has amended the user fee for the fiscal year 2022, and there is about a 2.5% rise in the fees for various medical device manufacturers, importers and distributors on the regulatory applications where…

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