MDR

MDCG has released guidance for classification of medical devices

The document provides practical examples of devices, including applicable rules and classifications.

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The device and certification module of EUDAMED is now open for registration and searches!

The EUDAMED device module was launched across the Europe on 4 October 2021, but the transition periods are defined on national level.

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Assessing the biological safety is a measure that protects both the user and manufacturer of a medical device.

The process for biological hazard identification and risk assessment is called biological safety evaluation. Often this means an evaluation and testing process based on the ISO 10993 standard.

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MD/IVD Regulation causes changes to national legislation in EU member states

 A new Finnish national legislation has entered into force.

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Guidance published by EU-commission on obligations and related rules for the registration in EUDAMED

To guide registration activities, EU-Commission has released a Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorized representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR in June.

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SWIXIT – Effects on the current status of the EU-Switzerland mutual recognition agreement (MRA) for medical devices markets

These should be noted by Swiss medical device manufacturers and legal manufacturer with Swiss Notified body or Swiss-based Authorized Representative.

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Do you know which designation codes are applicable to medical devices manufactured by your company?

When a manufacturer applies for conformity assessment from a notified body (NB), the type of devices and technologies subject to conformity assessment activities are to be indicated using designation codes.

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Notified Body – A business-critical relationship

Long-lasting relationships with notified bodies (NBs) are important and also business critical for many medical device manufacturers.

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Is your product a medicinal product, a medical device, or both?

Determining which legislation a product falls under is essential. When the question of which legislation applies to a product is not unequivocal, the term borderline products is used.

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What is a PRRC and why is it necessary to have one when the new MD Regulation enters into force?

One of the most significant new regulatory provisions is related to the increased requirements for internal monitoring by companies, namely the designation of a Person Responsible for Regulatory Compliance (PRRC).

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The MD Regulation is entering into force – is your quality management system in order?

If your company works in the field of medical devices, it is important for you to know that the new Medical Devices Regulation (MDR, EU 2017/745) requires all manufacturers of medical devices to have a quality management system.

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