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.
Link
- 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/
6 Replies to “MDCG, Team-NB, BVMed & Team-PRRC tell you all about PRRC”
Comments are closed.
Interesting approach, structured and easy to understand.
Great you like it
I know you discussed this in the webinar, but I’m still uncertain about the qualification of a PRRC. I am a South African citizen with a pharmacy degree obtained in South Africa. I’m working remotely for a UK based company and I’m newly appointed as their PRRC. Will my qualification still suffice?
Yes your qualifications looks fine. This is a science degree and will be equivalent to a degree in Europe I suppose. Listen to the podcast as they talk about that also.
I was interested in the database that one lady mentioned in the video, but I didn’t quite catch the name. Luckily, Google was able to understand what I meant by “Eric Naric” database. 🙂
Here is the link: https://www.enic-naric.net/
The ENIC-NARIC Networks are the result of an ongoing collaboration between the national information centres on academic recognition of qualifications of in total 55 countries.
Wahoo Sandra, you are awesome. Thanks for that. I will place this on the show notes