The European Union’s new Medical Device Regulation (MDR) has come into effect creating waves in the medtech community. EU MDR replaces the EU Medical Device Directive. The new regulations will provide more legal certainty and set higher standards of safety and quality for medical devices. The MDR was enacted in 2017 to concerns of safety of medical devices and lack of oversight over medical device manufacturers.

What does this mean for medtech in EU?

This simply means that the medical devices which are manufactured for use in the EU have to comply with the MDR standards. Medical Device Directive assessments will not be allowed to carry forward. There are four risk classes which have been announced and a third-party auditor, known as a ‘Notified Body’ will be involved in the regulation process. According to 

How does the MDR differ from MDD?

• Some medical devices will be placed in higher risk classes. These will require a conformity assessment by a Notified Body for the first time.
• The MDR lists out 23 general safety and performance requirements. There were 14 essential requirements which manufacturers had to consider under the MDD.
• Manufacturers will be responsible for formally appointing someone for compliance with the MDR.
• For most devices to be approved, they will require specific clinical data. This wasn’t a strict requirement before as general clinical literature was approved.
• Each medical device will have a unique device identifier. There are also increased requirements from labels and promotional materials. These will also need to be available in multiple EU languages.
• The MDR has also made clinical-follow ups and post-market surveillance stricter.
  
  Will there be complications because of Brexit?

UK discontinued being part of EU from January 1 2021. The MDR doesn’t apply to the UK, so the situation is a little tricky for them and Northern Ireland. For now, it has been decided that medical devices which have the MDR or MDD authorisation can be placed in the UK market till 2023. After 2023, these devices will be handled by UK Conformity Assessed marking requirements (UKCA). The UKCA has not been declared as a valid counterpart by the UK yet. So, products manufactured in the UK will have to be assessed by the body under MDR for it to be considered okay for use in the EU.