Establishing a robust Quality Management System (QMS) is a cornerstone of regulatory compliance for medical device manufacturers operating in the European Union. The EU Medical Device Regulation (MDR) (Regulation (EU) 2017/745) requires every manufacturer to implement and maintain a QMS covering the entire lifecycle of their devices—from design and development through post-market activities. While the … Read more
Authorised Representative / Responsible Person Service Under Articles 10 & 16 of the General Product Safety Regulation (EU) 2023/988 In summary: Why Choose Advena as Your EU Authorised Representative? Advena is one of the largest EC REP organisations within the EU. Representing a worldwide client portfolio. We offer a premium service at a competitive price, … Read more
Authorised Representative Service Under Article 5 the Toy Directive 2009/48/EC & Article 4(3) of Regulation (EU) 2019/1020 In summary: Why Choose Advena as Your EU Authorised Representative? Advena is one of the largest EC REP organisations within the EU. Representing a worldwide client portfolio. We offer a premium service at a competitive price, supporting clients … Read more
Authorised Representative Service Under Article 12 of the Machinery Regulation (EU) 2023/1230 & Article 4(3) of Regulation (EU) 2019/1020 In summary: Why Choose Advena as Your EU Authorised Representative? Advena is one of the largest EC REP organisations within the EU. Representing a worldwide client portfolio. We offer a premium service at a competitive price, … Read more
Authorised Representative Service Under Article 9 the PPE Regulation (EU) 2016/425 & Article 4(3) of Regulation (EU) 2019/1020 In summary: Why Choose Advena as Your EU Authorised Representative? Advena is one of the largest EC REP organisations within the EU. Representing a worldwide client portfolio. We offer a premium service at a competitive price, supporting … Read more
Authorised Representative Service Under Article 7 the Low Voltage Directive 2014/35/EU & Article 4(3) of Regulation (EU) 2019/1020 In summary: Why Choose Advena as Your EU Authorised Representative? Advena is one of the largest EC REP organisations within the EU. Representing a worldwide client portfolio. We offer a premium service at a competitive price, supporting … Read more
Authorised Representative Service Under Article 8 of the EMC Directive 2014/30/EU & Article 4(3) of Regulation (EU) 2019/1020 In summary: Why Choose Advena as Your EU Authorised Representative? Advena is one of the largest EC REP organisations within the EU. Representing a worldwide client portfolio. We offer a premium service at a competitive price, supporting … Read more
Are you Considering Selling your Medical Devices & IVD Devices in the European Union? Please remember that it is mandatory for medical device manufacturers located outside the EU to appoint an EU Authorised Representative. The EU REP plays a pivotal role in ensuring the compliance of devices produced by manufacturers who are located outside the … Read more
Article 13 MDR/IVDR Regulatory Importer Service Regulation (EU) 2017/745, the MDR & (EU 2017/746), the IVDR has introduced the regulatory role of Importer, one of four key roles in medical devices reaching and being sold in the EU, so how does this work? For this example, we will assume the manufacturer is based in Australia … Read more
Consultancy Services for Medical Devices & In Vitro Medical Devices At Advena we make it easy to talk and communicate so we best understand your requirements. Therefore, if you are interested in any of our services, we will make ourselves available, just follow these simple steps: Why Choose Advena for Your Consultancy Projects? For More … Read more
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EU Authorised Representative, Regulatory & Quality Consultants for Medical Devices
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