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EUDAMED

  • Eudamed
  • IVDR
  • MDR
  • UDI
  • UK MDR
IVDR, MDR

EUDAMED delay announced!

The European Commission has officially announced a delay in the full implementation of the EUDAMED database. As mentioned in a previous post, this delay will…

October 23, 2023
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Pablo De Mingo Monge 2023-10-23T11:27:14+02:00
IVDR, MDR

Update on EUDAMED state of play

The European Commission has released new minutes of the MDCG EUDAMED working group meeting of June 29, 2023. Among other topics covered in the minutes,…

September 4, 2023
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Pablo De Mingo Monge 2023-09-04T11:29:50+02:00
IVDR, MDR

Swissdamed: roll-out plan of the Swiss database on medical devices

Like the European Union, also Switzerland implemented the obligation to register medical devices and IVD medical devices marketed in their territory – to an online…

August 17, 2023
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Simona Varrella 2023-08-17T13:05:34+02:00
MDR

MDCG Q&A on MDR vigilance terms and concepts

The Medical Devices Coordination Group (MDCG) has issued new guidance clarifying important terms and concepts on vigilance stated in the Medical Devices Regulation (MDR) 2017/745.…

February 15, 2023
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Pablo De Mingo Monge 2023-02-15T14:09:17+01:00
MDR

MDCG Guidance on Period Safety Update Report (PSUR) under MDR

Manufacturers of class IIa, class IIb, and class III medical devices have to prepare a Period Safety Update Report (PSUR) for each device or group…

December 16, 2022
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Simona Varrella 2022-12-16T17:14:54+01:00
IVDR

MDCG template for substantial modification of performance study

Performance evaluation data can derive from performance studies. Data generated in performance studies must be reliable and robust, as stated in the Regulation on IVD…

December 15, 2022
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Simona Varrella 2022-12-15T11:56:53+01:00
IVDR

MDCG templates for performance study application and PMPF study notification

In December 2022, the Medical Device Coordination Group published various templates on performance study application and PMPF (Post Market Performance Follow-up) study notification. Documents for…

December 13, 2022
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Simona Varrella 2022-12-13T17:44:58+01:00
IVDR, MDR

Swissdamed: Database for Medical Devices in Switzerland

In Switzerland, Swissmedic enforces the registration of economic operators and medical devices. For this purpose, Swissmedic introduced a new database: Swissdamed. Swissdamed stands for “Swiss…

September 16, 2022
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Simona Varrella 2022-09-16T09:00:16+02:00
IVDR

Practices and alternatives until EUDAMED is fully functional

The new Regulations on medical devices (MDR) and in vitro medical devices (IVDR) introduced EUDAMED, a new traceability system for medical devices on the EU…

July 13, 2022
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Simona Varrella 2022-07-13T17:29:45+02:00
IVDR, MDR

EUDAMED Delayed!

The European Commission has announced a delay of the full functionality of the European database on medical devices (EUDAMED) and a new update of the…

July 6, 2022
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alejandro.gr@obelis.net 2022-07-06T16:40:25+02:00

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