- 12 March 2020
The Medical Device Regulation (MDR), published in May 2017, marked the beginning of a transition period that for medical devices will end up next May 26, 2020: MDR (EU) 2017/745 “application date”.
In general, MDR ...
- 6 March 2020
Food and Drug Administration (FDA) is working extensively to prevent the
possible consequences of the spread of Coronavirus (COVID-19) in relation to
medical devices, with the use of a coordinated approach that ...
- 12 February 2020
Transitional period until December 31, 2020.
As a result of Brexit from February 1, 2020 the transitional period was extended up to December 31, 2020, quite a wide time span, in ...
- 4 November 2019
This current rolling plan, used together with the “MDR & IVDR roadmap “, lists in chronological order the scheduled deadlines and the progress made on the implementing acts, the measures and ...
- 10 September 2019
One of the novelties introduced by Regulation (EU) 2017/745 is the Person Responsible for Regulatory Compliance, a professional entrusted with maintaining the compliance of the device and the organization.
Download the ...
- 30 April 2019
The strict regulatory requirements of MDR (EU) 2017/745 are about to hit hard a particular category of economic operators: the medical device Own Brand Label (OBL) manufacturers.
Own Brand Labelling ...
- 12 March 2019
Starting May 26th, 2020 (the MDR (EU) 2017/745 application date), medical device manufacturers will have to apply the MDR requirements for post-market surveillance (PMS), vigilance, registration of operators economic and ...
- 14 February 2019
On December 3, 2018, the European Commission
issued Regulation
(EU) 2018/1881, a specific revision of Regulation
(EC) no. 1907/2006 regarding the registration, evaluation,
authorization and restriction of chemicals (REACH), to include and regulate the
nanoforms ...
- 6 December 2018
Inspired by the “Qualified Person ” role present in the pharmaceutical field, the concept of Person Responsible for regulatory compliance is one of the changes introduced by the MDR (EU) 2017/745, ...
- 20 November 2018
This Infographic provides an overview of the clinical evaluation process as required by the MDR (EU) 2017/745 and the MEDDEV 2.7 / 1 rev. 4 and GHTF SG5 N2R8:2007.
It ensures ...
