All those in medical device industry must be aware that MDR (EU Medical Device Regulation) which was postponed for implementation due to corona pandemic. The due date in now approaching fast which is May 26, 2021. So, are you prepared all device manufacturers who are selling in Europe?
We are sure that you must be aware that changes between old MDD (Medical Device Directive) and MDR are significant and lot of new requirements have been added. (Its four times longer than MDD)
New changes are in consideration of new development that is happening in medical device industry. More stress has been given on safety and Efficacy.
Until today, medical devices were complying with the Medical Device Directive to sell their products in Europe. However major amendments are made in the current MDD to keep up with the growing technological advances in healthcare and medical devices. The new regulations passed by the Council of the European Union is Medical Device Regulations (MDR) 2017/745 that came into force in May 2017 & manufacturers have a transition time of three years until May 2020 to comply with the new regulations. Which was extended till May 2021.
Now let us know broadly what way industry get affected.
Is Your Product Existing or New?
Existing Product:You need to have additional of documentation as per MDR requirement as product is already in Market and proven. The term UOUP (User Interface of unknown Provenance) is used for existing (the product which is in market before February 2015 with no major design changes) Design changes needs to be reviewed that may impart it to NON UOUP status. This depends on type of design change.
New Product This will be treated as non UOUP product.
MDR requires compliance with International standard on usability engineering (IEC 62366-1:2015) This is different for different types of devices. MDR to scrutinise the devices as per this standard.
In Brief UOUP demands documentation,
1, Standard human factor like User specification, Intended use and user environment.
2. Use related risk analysis. If any minor design change then, additional risk analysis for that change.
3.Post Marketing surveillance data are UpToDate.
(Human factor validation study may not be needed.
Additional need in Non UOUP devices: User interface specification that requires labelling and training as well as testable technical requirement linked to user needs.
Depending on classification human factor validation will be needed.
There are many detailed things whether product needs to be tested in Europe like US FDA needs testing in USA. Are not discussed in this blog.
IZiel Healthcare has collaborated with Belgium based Obelis (European Authorized Representatives) to provide a “One-Stop Solution” to fully support Class I, IIa, IIb & III medical device manufacturers across USA, Europe & Asia. This collaboration would ensure to obtain conformity with the MDR (2017/745) requirements and maintain the CE Marking of global medical devices through technical support, consultancy, representation, and device registration services.