29th October 2019 – Introduction & Post-Marketing Surveillance 

 

 

08:45 – 09:00 

Registration 

09:00 – 09:15 

Opening 

Hon. Dr Deo Debattista 

Parliamentary Secretary for Consumer Rights, Public Cleansing and Support for the Capital City 

 

Prof Anthony Serracino Inglott 

Chairperson, Malta Medicines Authority 

SESSION ONE - INTRODUCTION 

09:15 – 09.45 

Medical devices classification and Drug- Device Combination products 

• What are medical devices? 
• How are these classified? 
• What are drug-device combination products? 


Coffee Break 

10:00 – 11:30 

Conformity assessments 

• What are conformity assessments? 
• What are the objectives of the assessments? 
• What is the conformity assessment procedure? 
• What are the general safety & performance requirements? 
• What is the declaration of conformity? 
• What is ISO 13485? 


11:30 – 12:30 

Medical device registration 

• What are the labelling requirements? 
• What is UDI and what are the requirements? 
• What is EUDAMED? 
• What are the registration requirements in the MDR? 
• What are the requirements for distributors, importers and authorised representatives? 


12:30 – 12:45 

Technological aspects of medical devices 

12:45 – 13:00 

Q & A 

Lunch 

SESSION TWO – POST-MARKETING SURVEILLANCE 

14:00 – 14:30 

Risk Management Plans 

• What is Risk? 
• What are Risk Management Plans? 
• How to design a risk management plan? 


14:30 – 15:30 

Incident reporting system 

15:30 – 16:30 

Field Safety Corrective Action 

16:30 – 17:00 

Round table discussion 

MAP, TOPRA and Manufacturer 

17:00 – 17:15 

Rapporteur – closing day remarks 




 

30th October 2019 – Medical Device Regulations & Parallel Sessions 

 

 

08:45– 09:00 

Registration 

Session Three – Medical Device Regulations 

09:00 – 10:00 

Medical Device EU Regulations 

• Overview of the EU Regulations and changes 
• Impact on Manufacturers, Wholesale Distributors, Retail 


Coffee Break 

10:15 – 10:45 

Malta Medical Device Regulations 

10:45 – 11:00 

Integrating research into regulation 

11:00 – 12:00 

In-Vitro Diagnostics 

• What are IVDs? 
• How are they classified? 
• What is the Regulation and how does it differ from the IVD Directive? 


12:00 – 12:15 

Pitfalls in In-Vitro Diagnostics: a clinician’s perspective 

12:15 – 12:30 

Q & A 

Lunch 

13:30 – 14:30 

EU Pathways for Biomarker Based Companion Diagnostic Development for Patient Stratification 

Parallel Sessions A & B: 

14:30 – 16:00 

Session A: Traceability of Medical Devices 

OR 

14:30 – 16:00 

Session B: Notified bodies 

• What are notified bodies? 
• How are they designated? 
• What are their responsibilities? 
• How does a manufacturer work with a notified body? 
• Current concerns with notified bodies and the MDR. 
• Notified body audits and technical reviews. 
• Summary of how to CE mark a medical device. 


 

16:00 – 16:30 

Rapporteurs feedback 

16:30 – 17.00 

Course evaluation and closing