EU MDR READINESS

 

Pointers in MDR

Clinical Evaluation

Risk Management

Quality Management System

Post-Market Surveillance

Technical documentation and other reports

Liability for defective devices

 

Evidence of Process-Oriented Life Cycle Approach

The current Medical Device Directive (MDD) is replaced with the Medical Device Regulation (MDR), which came into force May 2017, and must be implemented by May 2020.

The regulation emphasizes a life-cycle approach to Safety, backed up by Clinical Data and Clinical Evaluation.

Devices within EU have to be compliant with the new requirements, and reassessed to the new standards and state of the art.The MDR entails, amongst others, new requirements that strengthens Market Surveillance and Transparency in the field of Medical Devices.

The MDR reclassifies certain devices and has a wider scope in terms of cleaning, sterilising or disinfecting other medical devices Determining the risk class of a Medical Device is essential in specifying the steps required for CE marking. An assessment of conformity of your device may require involvement of a Notified Body.

 

Evidence of Process-Oriented Life Cycle Approach

The current Medical Device Directive (MDD) is replaced with the Medical Device Regulation (MDR), which came into force May 2017, and must be implemented by May 2020.

The regulation emphasizes a life-cycle approach to Safety, backed up by Clinical Data and Clinical Evaluation.

Devices within EU have to be compliant with the new requirements, and reassessed to the new standards and state of the art.The MDR entails, amongst others, new requirements that strengthens Market Surveillance and Transparency in the field of Medical Devices.

The MDR reclassifies certain devices and has a wider scope in terms of cleaning, sterilising or disinfecting other medical devices Determining the risk class of a Medical Device is essential in specifying the steps required for CE marking. An assessment of conformity of your device may require involvement of a Notified Body.

 

Pointers in MDR

Clinical Evaluation

Risk Management

Quality Management System

Post-Market Surveillance

Technical documentation and other reports

Liability for defective devices

 

WHAT IS MDR? 

The Medical Device Regulation, MDR is a strengthened set of expectations of available evidence and a process-oriented life cycle approach to ensure Quality, Performance & Safety of the Medical Device put in the European Market.  

The current available Medical Device Directive is published in 1993, more than 26 years ago. MDR is the new Medical Device Regulation which is formally published and entered into force on 25th May 2017. There is a three year transition period and the EU MDR must be implemented by MAY2020. 

HOW DO I PREPARE? 

If you work in the MedTech Industry and place products in the European Market, you are likely to be impacted by the MDR.

1. Familiarise yourself with the MDR regulation. 

2. Run an MDR GAP Assessment to identify, evaluate and implement any activities needed to comply with the expectations. 

3. Submit a Declaration of Conformity to the Authorised Authority.

 

FUTURE OPERATIONS 

MDR means that you have an increased focus on Ethics, Quality, Safety and Performance.

It means that you have a full governance of your business activities, pre- and post- market. 

MDR means that you will run a pro-active business that increasingly centres around focus on Patient Safety and Customer Satisfaction.

 

 

WHAT IS MDR? 

The Medical Device Regulation, MDR is a strengthened set of expectations of available evidence and a process-oriented life cycle approach to ensure Quality, Performance & Safety of the Medical Device put in the European Market.  

The current available Medical Device Directive is published in 1993, more than 26 years ago. MDR is the new Medical Device Regulation which is formally published and entered into force on 25th May 2017. There is a three year transition period and the EU MDR must be implemented by MAY2020. 

HOW DO I PREPARE? 

It you work in the MedTech Industry and put products in the European Market, you are likely to be impacted by the MDR.

1. Familiarise yourself with the MDR regulation. 

2. Run an MDR GAP Assessment to identify, evaluate and implement any activities needed to comply with the expectations. 

3. Submit a Declaration of Conformity to the Authorised Authority.

 

FUTURE OPERATIONS 

MDR means that you have an increased focus on Ethics, Quality, Safety and Performance.

It means that you have a full governance of your business activities, pre- and post- market. 

MDR means that you will run a pro-active business that increasingly centres around focus on Patient Safety and Customer Satisfaction.

 

 

Contact

Contact 13FOUR85 to start your tailor-made guided journey today.

+45 28 12 34 50

Contact

Contact 13FOUR85 to start your tailor-made guided journey today.

+45 28 12 34 50