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IVDR, MDR

New Team-NB position paper on medical device lifetime

Team-NB has released a document to clarify the concept of “medical device lifetime”. The Medical Devices Regulation (MDR) does not specifically provide a definition for…

December 18, 2023
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Pablo De Mingo Monge 2023-12-18T11:22:09+01:00
IVDR, MDR

Supply of medical devices in the EU: Survey & EU Authorities position

The European Commission and Members States are putting forward more steps to address the supply of medical devices in the EU. In this context, a…

December 4, 2023
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Pablo De Mingo Monge 2023-12-04T16:41:36+01:00
MDR

NB Position Paper on the new MDR transition timelines

On 10 August 2023, Team-NB, the European Association of Medical Devices Notified Bodes, published a position paper on the “New MDR Transition Timelines and Notified…

August 11, 2023
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Simona Varrella 2023-08-11T12:50:22+02:00
IVDR, MDR

Legacy device manufacturers: Important deadlines & steps

Legacy devices are devices that are typically covered by a valid CE Certificate or are being up-classified by the Regulations and benefit from a special…

August 10, 2023
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Pablo De Mingo Monge 2023-08-10T09:00:36+02:00
IVDR, MDR

CE recognition period extended: UK law officially published

On 14 June 2023, the UK Government published The Medical Devices (Amendment) (Great Britain) Regulations 2023. As mentioned in our previous post, Statutory Instrument 2023…

June 19, 2023
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Pablo De Mingo Monge 2023-06-19T16:20:42+02:00
IVDR

IVD legacy devices: MDCG Guidance on appropriate surveillance

The Medical Device Coordination Group (MDCG) has issued this September 2022 new guidance on the activities to be performed by the notified bodies as part…

September 15, 2022
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regulatory26@obelis.net 2022-09-15T12:31:17+02:00
IVDR

IVDR progressive roll-out has been officially published!

The Official Journal of the European Union (OJEU) has officially listed the amendment of the In Vitro Devices Regulation 2017/746, extending the transitional period for…

January 28, 2022
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regulatory26@obelis.net 2022-01-28T12:20:53+01:00

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