We are delighted to invite you to the7th EAAR Annual Conference on New Medical Device Regulations (RMD2023). Following the success of the Conference in Prague, Berlin, and Brussels, you will have the opportunity to gain a better understanding of the new European Regulations on medical devices at the Seventh EAAR (European Association of Authorized Representatives) Conference.
The application date of the Medical Device Regulation is already behind us. Moreover, two important events marked the medical device sector: Brexit and the lack of a Mutual Recognition Agreement between the EU and Switzerland. Consequently, a separate legislation applies in the EU, UK, and Switzerland. The Conference will give you an insight on how to approach these three markets, clarifying differences, common aspects and give you tips to successfully reach compliance.
- Where? Sheraton Brussels Airport Hotel, Belgium
- When? 2-3 February 2023
The panel of experienced professionals will cover a wide range of topics, among others:
- Online sales of medical devices
- Market surveillance from the point of view of the Competent Authorities
- Notified Body shortage and availability
- Issues related to CE and UKCA certification
- National Requirements additional to MDR – A Case Study: Spain
- MDR Clinical and IVDR performance evaluation
- Clinical investigations (MDR/IVDR)
- Solutions on implementing IVDR
- Standards, Harmonisation Process and Common Specifications
- PMS and vigilance
- Artificial Intelligence and medical devices
- General overview of future UK law by MHRA
- UKRPA perspective on the future UK law
- Switzerland and EU: impact on IVDs and medical devices
For more information, have a look at the RMD2023 website!