Two decades after the adoption of Directive 2002/46 / EC of the European Parliament and of the Council of 10...
Author: rapharm
EU: Joint implementation and preparedness plan for IVDR
The Medical Device Coordination Group (MDCG) has issued a Joint Implementation and Preparedness Plan for Regulation (EU) 2017/746 on in...
EU: Expert Panels on medical devices and in vitro diagnostics transferred to European Medicines Agency (EMA)
On 1 March, the Secretariat of the Commission’s expert panels on medical devices and in vitro diagnostic medical devices has...
Training in the field of medical devices: IMPACT OF THE NEW REGULATION ON IN VITRO DIAGNOSTIC MEDICAL DEVICES (IVDR) ON THE MANUFACTURE AND DISTRIBUTION OF IVD DEVICES AND LABORATORIES OF HEALTH INSTITUTIONS
24th May 2022, Microsoft Teams (Slovenian language) Training in the field of medical devices: IMPACT OF THE NEW REGULATION ON...
EU: Two new and one updated guideline have been published and approved by the MDCG
In February 2020, two new guidelines MDCG 2022-3 and MDCG 2022-4 and a new version of guideline MDCG 2021-21 Rev.1...
EU: On 25 January 2022, the European Parliament accepted Regulation 2022/112 amending the IVDR Regulation as regards transitional provisions for certain IVD devices and the deferred application of the conditions for in-house devices.
Regulation (EU) 2022/112 of 25 January 2022 was published in European Official Journal L 19/6 of 28 January 2022. The...
EU: New harmonized standards for MDR and IVDR regulation have been published
In the first week of January 2022, Commission Implementing Decisions (EU) 2022/6 on new harmonized standards for MDR and 2022/15...
Regulatory online workshop on medical devices: COMPLIANCE CHECK OF MEDICAL DEVICES PRIOR TO MAKING THEM AVAILABLE IN THE MARKET
On 15/02/202215/02/2022By rapharmIn Current educations and trainings, Regulatory news, Uncategorized
6th & 7th April 2022 Microsoft Teams (Slovenian language) Regulatory online workshop on medical devices: COMPLIANCE CHECK OF MEDICAL DEVICES PRIOR...
Regulatory 3-day online workshop on medical devices: GOOD PRACTICES TO MEET THE REQUIREMENTS OF NEW LEGISLATION IN THE FIELD OF DISTRIBUTION AND IMPORT OF MEDICAL DEVICES
22nd, 23rd & 24th March 2022 Microsoft Teams (Slovenian language) Regulatory 3-day online workshop on medical devices: GOOD PRACTICES TO MEET...
We welcome new colleagues to our team!
Due to the many opportunities and challenges that lie ahead, we would like to welcome new colleagues to our team!...