Introduction & Contents

Introduction...

The EU MDR Delay and Compliance

At the start of 2020, medical device companies were preparing for the EU Medical Device Regulation (MDR) date of application in May. However, in April 2020, with the unprecedented spread of COVID-19, the EU Commission took the step of postponing the date of application to 26th May 2021. This gave Medical Device, Software and Combination Product manufacturers an extra year to ensure their processes and products meet the increasingly stringent regulatory requirements.

Here in this interactive eBook, MedTech Summit takes an in-depth look at what the delay means for the medical device industry and how well prepared manufacturers are for EU MDR implementation, as well as exploring different aspects of the regulation.

Jump to any article using the contents on the following page, or at any time using the Contents menu in the top left. There you can also download this eBook as a PDF.

Contents

1. What does the EU MDR Deadline Delay Mean for the Medtech Industry?

Medtech insiders representing every aspect of the industry look at what the EU MDR delay means for medical device manufacturers, Notified Bodies, Competent Authorities and the EU Commission.

2. Implementing a Compliant Solution for the Electronic Distribution of Instructions for Use

Many manufacturers are now investigating the possibility of replacing the paper Instructions For Use with electronic IFU. European Regulatory Affairs consultants Qarad looks at the challenges, requirements and benefits of implementation of eIFU.

3. Manufacturing Incident Reports (MIR) under the EU MDR

The Manufacturer Incident Report (MIR) template aims for effective and transparent vigilance information exchange between manufacturers, Competent Authorities and Notified Bodies in the EU. This whitepaper looks at MIR under the EU MDR.

4. Video Panel Discussion: Update on the EU MDR Delay and Impact on Industry

With confirmation of the EU MDR delay due to COVID-19, MedTech Summit brought together four industry insiders to discuss the update and the impacts it will have on industry.

5. Data Study: The Industry View of EU MDR Implementation and Delay

Over the course of 2020, we have conducted numerous studies of the industry. Here we look at how the survey respondents view the EU MDR implementation and subsequent delay.

6. Article 117: Preparing Drug Device Combination Product Manufacturers for the EU MDR

Article 117 of the EU MDR has provided an amendment outlining specific requirements for drug device combination medical products. This whitepaper offers advice to prepare drug device combination product manufacturers for the new regulations.