Medical Technology Regulations for the EU market

The aim of this module is to allow participants to become competent in the regulations that govern Medical Devices in the EU market.  Especially new regulations recently introduced: 2017/745 (MDR) &/or In-vitro Diagnostics 2017/746 (IVDR).  A medical technology manufacturer must obtain CE mark with certification to place a device on the market.  In conjuntion with this process they must declare that they will conform with the relevant European regulations post release to ensure continued compliance. 

In addition to the introduction of new regulations for Europe, the arrangements for the U.K. market exit will be explored.  It will be imperative that students understand the signifiance that such variations involve for the regulatory professional and the medtech sector.  

1. Evaluate the key differences introduced in the new European regulations and identify the business impact and recommend steps to be taken for Medical Devices & Invitro Diagnostics.

2. Describe the current European Regulatory framework and demonstrate competency in knowledge of key regulators.

3. Demonstrate competency in the key CE marking processes.  Differentiate and formulate the relevant technical documents required for CE approval.

4. Prepare key procedures and templates to support European regulatory strategy and ensure consistent application and delivery.

5. Evaluate common specifications, guidance documents, standards relevant to CE marking process and regulatory intelligence sites.