Publications nexialist

News and updates

MHRA: The end of the transition period is coming … useful new guides!

In September, the UK's MHRA published two major guidances concerning the regulatory environment for medical devices (MD) in the UK, applicable from January 1, 2021 (end of the transition period): The first one, very comprehensive, relates to the regulation of MD after...

Reprocessing of single-use devices: long-awaited common specifications !

The Commission published on August 19 the Implementing Regulation (EU) 2020/1207 laying down rules for the application of the MD Regulation as regards common specifications for the reprocessing of single-use devices. This implementing Regulation lays down rules where...

GDPR compliance and transfer of data to third countries: the CJEU rules

In a major ruling on July 16 (see press release), the Court of Justice has provided us with guidance on what it considers to be "an adequate level of protection" for personal data transferred to a third country under the GDPR. It ruled on the inadequacy of the levels...

Minutes of the meeting held on 19 June: something new regarding harmonized standards !

•         The update of the list of harmonized standards under the 3 Directives is planned for the end of 2020. •         A new standardization request to CEN / CENELEC for harmonized standards under the Regulations is expected in the 1st quarter of 2021. •        ...
Corporate

BToHeath Day

Nexialist is taking part in the BToHeath Day, come and meet us on the 24th of November 2016 in Marseille at the Intercontinental Hotel. Nexialist is taking part in the BToHealth « The biomedical market within your reach !” day on the 24th November 2016. Do you want to...

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Digital Health

Regulation on the protection of personal data

Since the 14th April 2016, the European Parliment has adopted the (EU) n°2016/679 Regulation The Regulation (EU) 2016/679 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data was adopted by The...

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Electrical devices

Publication of 5 new information documents by the IMDRF

On the 2nd of October 2015, IMDRF published 5 information documents describing the application of some standards regarding medical devices in the countries, or group of countries, which are members of the IMDRF: Australia, Brazil, Canada, China, Europe, Japan, Russia...

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Clinical evaluation
General news

News and Updates

Welcome in the news and updates section! You will discover here everything about the MD industry and even more. Our Knowledge Management team will present you its bests articles & the Marketing our corporates news. You will find easily all your looking for in this...

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Regulation
Process/ Production

How to prepare for the DuPont Transition Tyvek

The transition from Legacy Tyvek® to Transition Tyvek® will take longer than planned. This means that manufacturers will have more time to carry it out. Discover here all the available tools to help you maintain compliance. DuPont™, the company that manufactures...

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Quality

MDCG

Risk management

Publication of 5 new information documents by the IMDRF

On the 2nd of October 2015, IMDRF published 5 information documents describing the application of some standards regarding medical devices in the countries, or group of countries, which are members of the IMDRF: Australia, Brazil, Canada, China, Europe, Japan, Russia...

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Unique Device Identification System (UDI System)

Publication of 5 new information documents by the IMDRF

On the 2nd of October 2015, IMDRF published 5 information documents describing the application of some standards regarding medical devices in the countries, or group of countries, which are members of the IMDRF: Australia, Brazil, Canada, China, Europe, Japan, Russia...

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Innovation

French High health authority: innovation refund plan

The innovation refund plan is a derogative and transitory way to obtain a payment from the French social security, which aims to make easier the access to new technologies and products. It can concern medical devices (MD), in-vitro diagnostic medical device (IVDMD) or...

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PMS / PMCF

MedTech Summit : 19-23 June 2017 in AMSTERDAM

nexialist is at the MedTech Summit : 19-23 June 2017 in AMSTERDAM We invite you to: Come and meet us at stand no. 6 from the 19th – 21st June Hear Julie Coste, Associate Director, speak on Post Market Surveillance a 12.00 on the 20th June. You are still in time to...

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Electrical devices

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