New EU Medical Device and In-Vitro Diagnostic Regulations

A medical device is a healthcare product or piece of equipment that a person uses for a medical purpose. Medical devices play a crucial role in improving the lives of patient and are used to diagnose, prevent and treat disease. The past number years have seen a significant improvement in medical device sciences and technologies which has transformed the industry for the better of the patient.

In response, the European Commission have approved new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) which are due to take effect on the 26 May 2020 and 26 May 2022 respectively. The new regulations came into effect on the 25th May 2017, however, a transition period has been given to allow manufacturers, notified bodies and authorities to adapt to the changes. The new regulations will replace the three existing directives ((93/42/EEC, 98/79/EC and 90/385/EEC)) which are in place since 1992 and represent a significant change, with the aim of improving the efficiency and safety of medical devices in the European Market.

There are four key objectives that are common across both regulations:

Improved performance of notified bodies for medical devices: Greater clarity in the requirements that a certification organisation must have in order to become a notified body for medical devices. National Authorities also have updated instructions on how to monitor performance of notified bodies on an ongoing basis, leading to improvements of the notified bodies.
Improved pre-market assessment of high-risk devices: An independent expert panel operating on behalf of an EU regulatory body to assess the devices before they are placed on the market. The panel can also be used to provide advice and guidance to manufacturers during the early stages of development.
Enhanced provisions for market surveillance: Both regulations outline obligations to be fulfilled by the regulators in terms of ongoing market surveillance which includes increased provisions for sampling and testing, increased assessment of regulatory compliance of devices and greater legal powers to address non complaint products.
Governance, coordination and cooperation: Both regulations have specific requirements and structures in place, where the national authorities are required to coordinate with each other, in conjunction with the European Commission.

Other changes that the new regulations will provide include;

All parties in the medical device supply chain have specific obligations as defined by the MDR and IVDR updates. This includes distributers and importers and will ensure devices are placed on the market in a compliant manner while maintaining the integrity of the supply chain.
A unique identifier will be placed on each device which will contain information about the manufacturer and other responsible parties. This information can be accessed by public and healthcare professionals through a central European database. This requirement will also enhance the traceability of devices in the event of a market recall.
More detailed requirements for clinical data on medical devices and its assessment: The updates outline the requirement to demonstrate safety and performance of a medical device during the clinical trial phases as well as increasing the amount of clinical data that is to be made available to the public and healthcare professionals.
The medical device regulation places greater emphasis and increases the possibilities to develop specific criteria and specifications for high risk medical devices.
The scope of the medical device regulations will broaden to include additional products which have previously not been regulated as medical devices, for example, liposuction equipment, colored contact lenses, dermal fillers, collagen implants, laser hair removal equipment and skin resurfacing equipment.

Further information on the new MDR and IVDR can be found on the HPRA website including the HPRA’s new “EU Device Legislation Information Pack”

PharmaLex can support the compliance of your organisation with the new regulations, including the provision of regulatory support, auditing and outsourcing solutions for medical devices. To discuss the range of services that we offer, please connect with us on +353 1 846 4742 or email us at contact@pharmalex.com.