Importers and Distributors of medical devices
The main players involved in trade with a medical device in the broadest sense are defined in the Regulation (EU) 2017/745 (MDR) in Article 2; (30) “manufacturer”, (32) “authorised representative”, (33) “importer” and (34) “distributor”.
According to the MDR, not only manufacturers and their authorised representatives, but also distributors and importers of medical devices must meet extensive requirements. These requirements must be met both before and after medical devices are placed on the market or made available on the market.
In our interactive seminar, we will explain the various obligations and tasks of distributors and importers and show you possible consequences that you will face in the event of non-compliance.
In addition, we will give you helpful tips on how to efficiently meet the various requirements.
Content
- Economic operators of the MDR
- Duties and obligations of importers
- Duties and Duties of distributors
- Special acts according to Article 16 of the MDR
- Documentation Retention Periods
- Penalties and liability
Your benefits
- In this introduction, you will get an overview of the various tasks and obligations for distributors and importers.
- You will know what penalties you will face if you do not meet the requirements.
- You will get useful tips to complete the tasks efficiently.
Trainer
- Timo Bohnhoff
Participants
- Importers of medical devices and those who want to become one
- Distributors of medical devices and those who want to become distributors
- Employees who want to familiarize themselves with the obligations of importers and distributors
Further recommendations on “Importers and distributors of medical devices”
- Medical Device Regulation
- Economic Operator Manufacturer
- Person responsible for regulatory compliance (PRRC)
Sprache: Englisch
Durchführung: Remote
Dauer: 3 h
Kategorie: Englische Seminare
Anbieter: qtec services GmbH
Geeignet für: Importers of medical devices, Distributors of medical devices, Employees
Vorkenntnisse: not required
Referent
Timo Bohnhoff
Senior QA and RA Manager
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Tags: Economic operators of the MDR Duties and obligations of importers Duties and Duties of distributors Special acts according to Article 16 of the MDR Documentation Retention Periods
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Importers and Distributors of medical devices
The main players involved in trade with a medical device in the broadest sense are defined in the Regulation (EU) 2017/745 (MDR) in Article 2; (30) “manufacturer”, (32) “authorised representative”, (33) “importer” and (34) “distributor”. According to the MDR, not only manufacturers and their authorised representatives, but also distributors and importers of medical devices must meet extensive requirements. These requirements must be met both before and after medical devices are placed on the market or made available on the market.
Referent
Timo Bohnhoff
Senior QA and RA Manager
| Sprache: | Englisch |
| Durchführung: | Remote |
| Dauer: | 3 h |
| Kategorie: | Englische Seminare |
| Anbieter: | qtec services GmbH |
Geeignet für:
Importers of medical devices, Distributors of medical devices, Employees
267,00 EUR
Preis netto zzgl. Mwst. pro Teilnehmer
buchenInhouseschulung anfragen
