The key objectives of the new EU medical device regulations

The past number years have seen a significant improvement in medical device sciences and technologies that have transformed the industry for the better of the patient.

A medical device is a healthcare product or piece of equipment 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.

Medical devices Photo by Daniel Frank from Pexels
Medical devices play a crucial role in improving the lives of patient and are used to diagnose, prevent and treat disease

The European Commission have approved new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) which are due to take effect on 26 May 2020 and 26 May 2022 respectively. The new regulations came into effect on 25May 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, co-ordination and co-operation: Both regulations have specific requirements and structures in place, where the national authorities are required to co-ordinate with each other, in conjunction with the European Commission.

 Other changes the new regulations 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, coloured 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 supports the compliance of your organisation with the new regulations, including the provision of regulatory support, auditing and outsourcing solutions for medical devices.



Latest


26 Feb 2021
Melcura HoneyGel revolutionises at-home wound care

Medika SA trading as the Melcura brand, a trusted and well-established wound care brand that has been based in hospitals…

Melcura HoneyGel revolutionises at-home wound care

Medika SA trading as the Melcura brand, a trusted and well-established wound care brand that has been based in hospitals for over 15 years, has finally launched online and at select local pharmacies. Melcura products are a crucial component in one’s arsenal for fast, complete wound healing when an accident…

25 Feb 2021
Environ is named Top Medical Skincare Line of the Decade

Environ Skin Care has won the award for Top Medical Skincare Line of the Decade. With a long list of…

Environ is named Top Medical Skincare Line of the Decade

Environ Skin Care has won the award for Top Medical Skincare Line of the Decade. With a long list of over 100 highly esteemed recognitions received for outstanding products worldwide, South African born, globally recognised professional brand Environ Skin Care has been on an international winning streak the past few…

25 Feb 2021
Adcock Ingram reports resilient trading performance despite COVID-19 challenges

The Adcock Ingram Group has achieved a 4% increase in turnover for the six month period to 31 December 2020.…

Adcock Ingram reports resilient trading performance despite COVID-19 challenges

The Adcock Ingram Group has achieved a 4% increase in turnover for the six month period to 31 December 2020. The company achieved these results despite challenging trading conditions caused by COVID-19, a depressed economy and decline in demand for certain categories of medicine and products. Performance metrics include: •         …

24 Feb 2021
Virtual conference drives the goal to buy Africa for Africa

The Made in Africa Conference and Expo will be the largest ever virtual gathering of and showcase of African buyers…

Virtual conference drives the goal to buy Africa for Africa

The Made in Africa Conference and Expo will be the largest ever virtual gathering of and showcase of African buyers and sellers, taking place on 13 and 14 April 2021.   With the COVID-19 pandemic pushing African nations to develop local solutions to the continent’s challenges, the time has come…


Top stories


25 Jun 2020
How to ensure business agility in a pandemic

BY: Neil Birch, CEO at Novus Holdings Business agility is the capability of a business to respond quickly to a…

How to ensure business agility in a pandemic

BY: Neil Birch, CEO at Novus Holdings Business agility is the capability of a business to respond quickly to a changing environment, whether it be internal or external. Qualities of agile businesses include being adaptive, flexible and creative in your response to change without losing momentum (remaining productive) or vision.…

01 May 2020
Fibertex manufactures critical components for COVID-19 PPE

Fibertex SA, part of the global Fibertex Nonwovens group, has developed versatile high-performance components for protective facemasks and respirators. “Fibertex,…

Fibertex manufactures critical components for COVID-19 PPE

Fibertex SA, part of the global Fibertex Nonwovens group, has developed versatile high-performance components for protective facemasks and respirators. “Fibertex, which continuously invests in technological advancements to meet requirements in diverse industries – has increased production capacity of materials so desperately needed during the global COVID-19 pandemic,” explains Rosa Naidoo,…

23 Apr 2020
Are you South Africa’s best female entrepreneur?

Entries are now open for the Santam Women of the Future Awards 2020 in association with Fairlady and True Love.…

Are you South Africa’s best female entrepreneur?

Entries are now open for the Santam Women of the Future Awards 2020 in association with Fairlady and True Love. Santam, Fairlady and, for the first time this year, Truelove Magazine, have partnered up in the search to find the best female entrepreneurs in the country. Best women entrepreneurs If…

30 Nov 2017
Rooibos could reduce risk of “Type 3” diabetes – a precursor to Alzheimer’s

Researchers at Warren Alpert Medical School at Brown University in the US found a link between a relatively new form…

Rooibos could reduce risk of “Type 3” diabetes – a precursor to Alzheimer’s

Researchers at Warren Alpert Medical School at Brown University in the US found a link between a relatively new form of diabetes, known as “type 3” diabetes and Alzheimer’s disease.


Visit the official COVID-19 government website to stay informed: sacoronavirus.co.za