What you need to know about the new EU Regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR).
Overview
This guidance provides information on the new EU Regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR).
Medical device types and their associated regulation
The 2 main medical devices and their associated regulations are:
- general medical devices: The EU Regulation on Medical Devices 2017/745
- in vitro diagnostic medical devices (IVDs): The EU Regulation on In Vitro Diagnostic Medical Devices 2017/746
You must meet the requirements in the relevant Regulation before your device can be placed on the market.
Introductory guide to MDR IVDR
We have created an interactive guide to the
Placing a device on the market under the new Regulations
The Regulations ‘entered into force’ on 25 May, which is when the three- and five-year transition periods began. Therefore, the MDR and IVDR will fully apply in EU Member States from 26 May 2020 and 2022 respectively.
During the transition period, devices can be placed on the market under the current EU Directives, or the new Regulations (if they fully comply with the new Regulations).
However, devices placed on the market after the transition period will need to fully comply with the MDR, unless they wish to make use of the extended period of CE certificate validity.
This allows for CE certificates issued under the current Directives and within the transition period referred to above to remain valid for a maximum period of four years (MDR) and two years (IVDR) after the date it was issued.
However, a number of MDR/ IVDR provisions will ‘switch on’ at the date of full application and the original certifying notified body must also be designated under the new Regulations to qualify.
How to comply with the legal requirements
If you are manufacturing a medical device, you must meet new obligations set out in the Regulations. You will need to ensure:
- the device has been correctly classified against the new risk classification criteria (Annex VIII of the MDR and IVDR)
- general safety and performance requirements are met, including for labelling and technical documentation and quality management systems (Annex I of the MDR and IVDR)
- increased requirements for clinical evidence are met (Annex XIV of the MDR and IVDR)
- manufacturers have a person responsible for regulatory compliance in place (Article 15 of the MDR and IVDR)
- economic operators in the supply chain are compliant
- sufficient financial coverage is in place, in respect of a manufacturer’s potential liability (Article 10 of the MDR and IVDR)
- the new vigilance reporting timescales are met and that an annual periodic safety update report is created (Chapter VII, Section 1 and 2 of the MDR and IVDR)
There are number of other obligations that must be met, which can be found in Article 10 of the MDR and the IVDR.
You should also note that the IVDR will bring in some key changes that will impact on manufacturers of IVDs. Please be aware that:
- changes to classification rules for IVDs will mean that 80-90% of IVDs will require a notified body to conduct a conformity assessment
- manufacturers of IVDs will be required to produce significantly more performance evidence, which will need to be updated throughout the life cycle of the device
- the performance and testing of Class D devices will need to be verified by reference laboratories
- there will be a new consultation procedure for companion diagnostics