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IVDR (EU) 2017/746 Factsheet for Manufacturers of in vitro Diagnostic Medical Devices

The White Paper “Factsheet for Manufacturers of in vitro Diagnostic Medical Devices” explores the in vitro Diagnostic Medical Devices Regulation (IVDR) from the point of view of the Manufacturers. The document provides information on the obligations and requirements must be fulfilled in order to be ready on 26 May 2022, the date of full application [...]

2021-04-28T14:47:50+02:00April 28th, 2021|LIBRARY|

Medical Devices Labelling: instructions for use

The White Paper “Medical Devices Labelling: instructions for use” explains, from the regulatory point of view, what are the labelling requirements for Medical Devices according to the MDR (EU) 2017/745 Regulation. It is mandatory and fundamental to apply the requirements for the labelling of Medical Devices as the information on the product label helps the [...]

2021-04-23T17:40:23+02:00April 23rd, 2021|LIBRARY|

UK: BREXIT, what changes from 1 January 2021

On September 1, 2020 the Medicines and Healthcare products Regulatory Agency (MHRA) published new rules to be respected for placing and the registering a medical device on the UK market, from 1 January 2021. The guideline is indicative and not definitive, as a new legislation will have to obtain parliamentary approval. BREXIT what changes from [...]

2022-07-26T17:46:58+02:00October 22nd, 2020|Brexit Eng, News|

MDR & IVDR Rolling Plan Infographic

The following infographic highlights, in chronological order, the scheduled deadlines and the progress of the work with regard to the implementing acts, the measures and initiatives necessary to apply the MDR Medical Devices Regulation and the IVDR Regulation in time. The infographic is taken from the "rolling plan" and "MDR & IVDR roadmap" made available [...]

2020-05-20T17:33:59+02:00May 20th, 2020|LIBRARY|

Factsheet for Authorised Representatives, Importers and Distributors of Medical Devices and in vitro Diagnostic Medical Devices

By reading our  White Paper "Factsheet for Authorised Representatives, Importers and Distributors of Medical Devices and in vitro Diagnostic Medical Devices" you will get detailed information on: Economic Operators’ operating context;the regulatory changes introduced by the MDR (EU) 2017/745 and the IVDR (EU) 2017/746 ;new requirements related to Economic Operators. Fill in the form and [...]

2020-04-27T15:31:11+02:00April 27th, 2020|LIBRARY|

Own Brand Labelling (OBL) of Medical Devices in the European Union: the end of an era?

Read our White Paper "Own Brand Labeling (OBL) of Medical Devices in the European Union: the end of an era?" and immediately learn more about: the OBL (Own Brand Labeling) - OEM (Original Equipment Manufacturing) context under the current European legislative framework;the regulatory changes introduced by the European Regulations MDR (EU) 2017/745 and the new [...]

2019-05-23T10:23:01+02:00May 23rd, 2019|LIBRARY|

Nanomaterials: the safety evaluation and risk assessment in Medical Devices

Read our White Paper "Nanomaterials: the safety evaluation and risk assessment in Medical Devices" and get further information on: the biological evaluation nanomaterials-based MD;risk assessment of invasive Medical Devices;the MDR (EU) 2017/745 regulatory framework on nanomaterials use. Nanomaterials - the safety evaluation and risk assessment in Medical Devices Fill in the form and receive the White [...]

2018-11-30T16:40:04+01:00November 30th, 2018|LIBRARY|
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