As it stands now, all medical devices must comply with the Medical Device Directive (MDD) or the Active Implantable Medical Device Directive (AIMDD). But by 2020, this will change and new medical device products distributed within Europe must comply with the new European Medical Device Regulation (EU MDR).
The size of the organization does not matter — EU MDR does not draw distinctions – so whether you are a large Enterprise or SME organization – you have to comply, as well as prepare for future regulations.
It has been said that Europe’s MDR (EU MDR) is the most significant change to the regulatory framework in the medical device industry since CE Marking was introduced in 1993.
Gap analysis can be conducted by trained internal or external (consultants). The specific scope would depend on many variables (experience, classification, number of legacy devices, available/quality clinical data, compliance with state of the art). During transition, lots of guidance is not yet available, so [the] judgement of experts is critical to ensure gaps are correctly identified and addressed.
Understand the expectations and prepare the data, irrespective of whether EUDAMED is functioning to receive the data. Manufacturers must address the data requirements and have [their data] available.
Implementation of the EU MDR can be complex and challenging. As you implement, it is important to understand if your plan is going in the right direction, or not.
The new EU MDR Regulations contain a series of extremely important improvements to modernise the current system. Among them are:
The EU MDR has a transition period of three years and will fully apply from 26 May 2020.
Until now there are 5 Notified bodies designated under EU MDR.
The new EU MDR regulations will ensure:
We have ramped up our services and are making sure that we’re available to meet these really tight deadlines of EU MDR. Please feel free to connect and resolve your compliance gaps ahead of time.
Amended transition timelines of Regulations (EU) 2017/745 and (EU) 2017/746Read More
European Commission to consider extensions to MDR and IVDR deadlines?Read More
Quantification of Benefit – Risk AnalysisRead More