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Regular training in the field of regulatory medical devices: FULFILLMENT OF OBLIGATIONS FOR THE IMPORT AND DISTRIBUTION OF MEDICAL DEVICES

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On 09/11/202309/11/2023By rapharmIn Current educations and trainings

24th January 2024, Radisson Blu Plaza Hotel Ljubljana Regular training in the field of regulatory medical devices: FULFILLMENT OF OBLIGATIONS...

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Training in the Field of Medical Devices: PREPARATION FOR INSPECTION CONTROL OVER IMPLEMENTATION OBLIGATIONS OF IMPORTERS AND DISTRIBUTORS MEDICAL DEVICES

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On 06/09/202309/11/2023By rapharmIn Current educations and trainings

24th October 2023, Radisson Blu Plaza Hotel Ljubljana Training in the Field of Medical Devices: PREPARATION FOR INSPECTION CONTROL OVER...

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Regulatory workshop on medical devices: COMPLIANCE CHECK OF MEDICAL DEVICES PRIOR TO MAKING THEM AVAILABLE IN THE MARKET

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On 12/04/202318/04/2023By rapharmIn Current educations and trainings

8th June 2023, Radisson Blu Plaza Hotel Ljubljana (Slovenian language) Regulatory workshop on medical devices:COMPLIANCE CHECK OF MEDICAL DEVICES PRIOR...

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Training in the Field of Medical Devices: WHAT DOES THE JAZMP (PUBLIC AGENCY) MANUAL BRING FOR MEDICAL DEVICE DISTRIBUTORS?

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On 12/04/202318/04/2023By rapharmIn Current educations and trainings

25th May 2023, Radisson Blu Plaza Hotel Ljubljana (Slovenian language) The training is intended for medical device distributors who want...

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EU: New limitation of ingredients in food supplements

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On 03/01/202318/04/2023By rapharmIn Novice

In connection with Article 8(2) of Regulation (EC) no. 1925/2006, the Commission adopted Regulation no. 2022/2340, which restricts the use...

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EU: Two new guidelines have been published and approved by the MDCG

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On 27/10/202227/10/2022By rapharmIn Novice, Uncategorized

On 14 September, two new guidelines, MDCG 2022-15 and MDCG 2021-22, were published on the website of the European Commission...

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EU: Beauty claims vs. health claims on foods

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On 18/10/202203/02/2023By rapharmIn Novice

In the last years, there has been an increase in fortified foods and food supplements that primarily target the female...

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EU: On 4 July 2022, the European Commission accepted Implementing Regulation 2022/1107 laying down common specifications for certain class D in vitro diagnostic medical devices (IVDs) in accordance with Regulation (EU) 2017/746

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On 08/07/202211/07/2022By rapharmIn Novice, Uncategorized

In the document European Commission explains that for certain class D IVDs harmonised standards do not exist and since the...

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EU: MDCG Position paper has been published

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On 21/06/202221/06/2022By rapharmIn Novice, Uncategorized

In June, a Position paper MDCG 2022-11 was published on the website of the European Commission and approved by the...

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EU: New guideline has been published and approved by the MDCG

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On 17/06/202217/06/2022By rapharmIn Novice, Uncategorized

In May, a new guideline, MDCG 2022-8 was published on the website of the European Commission and approved by the...

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About raPHARM

raPHARM is a consultancy and education office specialising in pharmaceutical and medical devices regulatory affairs. The office was founded by Ms Vesna Koblar, MD. PhD., an internationally recognised expert in this area with extensive experience and knowledge.

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  • raPHARM, Ltd.
  • 30 Miklošičeva Street
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