General

Demystifying Swiss Authorized Representative Requirements

By Syed Hassan0 CommentsGeneral
For the foreign manufacturers who want to place their products on the Swiss medical device market, it is necessary to appoint a Swiss Authorized Representative. However, an agreement must be ensured between the manufacturer and the Representative before the Representative’s appointment. Need of the Swiss Authorized Representative For the non-Swiss…
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Important Guidelines for MDSAP

By Syed Hassan0 CommentsGeneral
The MDSAP (Medical Device Single Audit Program) is a three-year-long audit cycle. These cycles can be listed down as follows: The Initial Audit Cycle Partial Surveillance Audit Complete Re-audit The Initial Audit Cycle The initial audit cycle is the first year audit cycle and is also known as “Initial Certification…
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EU MDR Article 18 – Medical Device Implants

By Waqas Imam0 CommentsGeneral
Article 18 of MDR addresses the need for an implant card for implantable medical devices. For an Asian implantable devices manufacturer, fulfilling the requirements of EU MDR Article 18 without an EU Authorized Representative might not be possible. What are the Requirements of EU MDR Article 18? EU MDR Article…
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Technical File or Design Dossier Management – EU MDR

By Waqas Imam0 CommentsGeneral
A CE Technical File or Design Dossier is a complete description for a medical device intending to show compliance with EU MDR’s requirements. For a medical device manufacturer, preparing a technical file or design dossier is an essential step in Europe’s CE marketing process. What does the Technical File/Dossier Contain?…
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EU PRRC – Person Responsible for Regulatory Compliance

By Waqas Imam0 CommentsGeneral
The new regulations, i.e., EU MDR (2017/745) and EU IVDR (2017/746) have made regulatory requirements for medical device manufacturers more stringent. It is now mandatory for medical device manufacturing companies to ensure that they have a qualified and competent Regulatory Expert who can help them become compliant with the new…
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EU MDR 2017 – 745 (Medical Device Regulations)

By Waqas Imam0 CommentsGeneral
What are Medical Devices? Medical devices are the medical equipment and devices used for in vitro tests. These devices are either used in hospitals by healthcare professionals or directly by a patient. The EU market contains around 500,000 different types of medical devices. All of these devices are used for…
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