Product Safety in Pharma & MedTech

product safety pharma

In the European Union, medicinal products and medical devices are only approved for the market if manufacturers can guarantee the safety of their products. If adverse events occur after the products have been placed on the market, the vigilance procedures of the respective industries take effect. This is because patient safety continues to be a […]

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XML Bulk Upload Explained

XML-Bulk Upload

With a go-live date for the EUDAMED next year and a deadline for the Medical Devices Regulation (MDR) in the not-too-distant future, it is important to take care of your product data now. There are three ways to upload the data to EUDAMED: using an M2M interface, by manual entry, or via bulk upload of […]

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Collect your product data now

collecting product data medical devices

The extension of the MDR transition periods came at the right time for many companies. A survey by the Medical Device Coordination Group (MDCG) in April 2022 found that a total of 85% of medical devices certified under the Medical Device Directive (MDD) and Active Implantable Medical Devices Directive (AIMDD) are not yet certified for […]

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Agile meets Post-Market Surveillance

Agile meets Post-Marketing Surveillance

Medical device manufacturers are required by the MDR/IVDR to monitor the safety of their products even after they have been approved and have entered the market. This process is called Post-Market Surveillance (PMS) or Post-Marketing Surveillance. Due to the considerable amount of work involved, it can be advantageous to outsource this process to other companies. […]

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MDR Transition Periods Extension

MDR transition period extension

On January 06, 2023, the European Commission (EC) published a proposal for the extension of the MDR (Medical Device Regulation) transition periods. This proposal was already adopted on February 16, bringing the extension into force. The obligation of medical device manufacturers to be MDR compliant was thereby postponed several years into the future. Reason for […]

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Custom-made devices in the MDR

Custom-made devices MDR

A custom-made device in MedTech is a product prescribed to a patient by an authorized person, such as a physician. This product, by prescription, is manufactured exclusively for the respective person. Mass products with adaptions adjusted to fit the user’s needs are not considered as custom-made devices. Custom-made devices were already part of the Medical […]

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MDR – Market Entry Consideration for MedTech Products

Market Entry Consideration

What requirements must a product fulfill before it can ultimately be sold in the EU? This question is answered in the second chapter of the Medical Device Regulation (MDR). It includes information on placing products on the market, commissioning, and the role of authorized representatives. The responsibility for this lies with manufacturers, importers, and distributors. […]

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