Two decades after the adoption of Directive 2002/46 / EC of the European Parliament and of the Council of 10...
Category: <span>Uncategorized</span>
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...
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...
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...
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!...
Regulatory workshop on medical devices: COMPLIANCE CHECK OF MEDICAL DEVICES PRIOR TO MAKING THEM AVAILABLE IN THE MARKET
On 04/12/201925/10/2021By rapharmIn Current educations and trainings, Regulatory news, Uncategorized
Third term: 26th March 2020 – CANCELLED (COVID-19) raPHARM premises, 30 Miklošičeva Street, Ljubljana (Slovenian language) Fourth term: 9th April 2020 –...
Regulatory workshop: PREPARATION OF DOCUMENTED PROCEDURES FOR MEETING THE REQUIREMENTS OF THE NEW REGULATION IN THE FIELD OF DISTRIBUTION OF MEDICAL DEVICES
On 25/03/201921/02/2020By rapharmIn Current educations and trainings, Regulatory news, Uncategorized
Additional term: Date to be determined raPHARM premises, Miklošičeva 30, Ljubljana (Slovenian language) Regulatory workshop PREPARATION OF DOCUMENTED PROCEDURES FOR MEETING THE REQUIREMENTS...
Regulatory seminar and workshop on medical devices: NEW LIABILITIES AND RESPONSIBILITIES OF DISTRIBUTORS OF MEDICAL DEVICES IN THE EU – Why to review current agreements?
On 25/09/201819/10/2018By rapharmIn Current educations and trainings, Regulatory news, Uncategorized
27th & 28th November 2018 Radisson Blu Plaza Hotel Ljubljana (Slovenian language) Regulatory seminar and workshop on medical devices NEW LIABILITIES...