MDCG, Team-NB, BVMed & Team-PRRC tell you all about PRRC
Imagine that you have a question to ask the EU Commission, your Notified Body, or any association about being a PRRC. Then this is the episode to listen to. During the Team-PRRC event on November 3 and 4 2022, I was able to record some of the sessions and propose them to you know. Here are the people that were on the panel:
- Bassil Akra, Board Member of Team-PRRC association as the facilitator https://www.linkedin.com/in/bassil-akra-2388b84b/
- Mario Gabrielli Cossellu – EU Commission https://www.linkedin.com/in/mariogabriellicossellu/
- Orla Daly – EU Commission https://www.linkedin.com/in/orla-daly-354128b4/
- Francoise Schlemmer – Team-NB https://www.linkedin.com/in/francoise-schlemmer-baa16011/
- Christopher Kipp – BVMed https://www.linkedin.com/in/christopher-kipp-b16ba71b1/
And here are the questions answered:
- Why a PRRC is needed
- Will Notified Bodies issue an NC when manufacturers have no PRRC when they are following the MDD directive?
- What does it mean to ensure compliance for a PRRC?
- What notified bodies are expecting from PRRC to ensure compliance
- Is it the intention of the regulation to put PRRC in Jail?
- Can a CEO be a PRRC for its company?
- Lake of resources to help manufacturers?
- PRRC Training?
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
- Team-PRRC association: https://www.team-prrc.eu/
- EU Authorized Representative: https://easymedicaldevice.com/eu-rep/
- UK responsible person: https://easymedicaldevice.com/uk-responsible-person/
- Swiss representative: https://easymedicaldevice.com/swiss-authorised-representative/
- Enic-Naric database: https://www.enic-naric.net/