Aug 7, 2020

The latest on EU medical device regulations

medical devices
eu regulation
medical device manufacturers
Compliance
Leila Hawkins
3 min
The latest on EU medical device regulations
Medical device manufacturers trading with an EU country are facing a number of new rules. Here's a summary of the latest developments...

A medical device is defined as any product or piece of equipment designed for medical use. New developments in technology have resulted in the line between medicine and medical equipments becoming increasingly blurred. The new regulations will monitor health and safety and stop identified hazards from entering the European market. 

The EU first passed the Medical Device Regulation (EU MDR) in 2017 to replace the previous EU Medical Device Directive (MDD). The aim of the MDR is to ensure compliance and consistency. 

The MDD was a directive, however the new MDR is a law. This is comparable to the Food & Drug Administration (FDA) in the US. 

A range of new products will also be covered by the MDR for the first time. This will include products used to sterilise medical devices and products that support and control conception. 

A transition period of three years was originally set by the MDR, with a deadline of May 26, 2020. However as a result of the COVID-19 pandemic this has been extended to May 26 2021. From this date onwards, manufacturers will have to meet the requirements of the MDR to sell new products to European countries. 

The UK will have fully exited the European Union by this time. Regulations for the UK will depend on the British government’s negotiations. Their current guidance states that decisions on regulations will be based on patient safety and access

The MDR includes a number of new conditions for existing devices. Any that are not re-certified will have to be retired from use. Clinical data and technical documents will need to be updated with the latest specifications. Aspects of risk, type and duration of contact will have to be reclassified. 

Manufacturers will be required to obtain clinical data from studies and clinical investigations, which will be carefully scrutinised. This means a past clinical evaluation report may no longer be acceptable. Manufacturers will also be responsible for creating a system that documents the entire lifecycle of a device. Storage of documents, quality control and risk assessment need to be documented.  

Another requirement is translating instructions into 24 EU languages, which will become the responsibility of the manufacturer. 

The process of gaining a certificate could result in delays due to the capacity of the certification bodies. In cases where a device needs to be reclassified this may require additional data and documentation. 

Consultancy firm Bain & Company predict that one-time certification costs fall between 5 - 10 per cent of EU revenue. Ongoing costs of complying with the regulations are expected to rise between 10 - 20 per cent. 

Recommendations

  • The most important step is to act fast. From May 2025 devices certified under the old MDD will need to come off the market. After May 2022, certificates of conformity issued before May 2017 will automatically expire. Delays to reviews and the approval process should be expected. 
  • Get rid of obsolete products to minimise delays
  • Plan ahead in case of compliance issues and increases in costs caused by the new process
  • Stay up to date on the progress of the MDR through the regulatory approval process. Also, monitor any other changes that may impact on the regulations. 

Share article

Jul 16, 2021

Vuram launches automated app to track COVID-19 supplies

COVID19
Automation
supplychain
Technology
2 min
Vuram launches automated app to track COVID-19 supplies
Vuram's Trackable app uses automation to monitor COVID-19 essential supplies in real time

A new app that tracks COVID-19 supplies in real time time has launched. 

Built by hyper-automation services company Vuram, Trackable can monitor the progress of vaccines, oxygen cylinders, PPE, and masks as they move through the supply chain. 

The app's features include street view to facilitate coordination between drivers, and trained facial recognition software powered by Microsoft Azure to ensure goods are only handled by authorised personnel. 

Other functions include: 
 * Demand management for inventories, to prioritise deliveries using automation
 * Demand analysis to predict sales trends based on stock levels
 * Offline multilingual feature for drivers
 * A dashboard to see the status and location of drivers
 * Insights on how products are performing in real-time 

The team at Vuram built Trackable as part of the Appian World 2021 Online Hackathon, where participants can take their ideas for innovative software and create a custom app. The tracking app went on to win the contest. 

“Custom component building is at the heart of this application, and we focussed on making them more creative to provide an improved user experience" said Santosh Kumar, co-developer of Trackable.

"We are happy that we have managed to make it to the top in just a month. On behalf of Vuram, I thank the Appian Hackathon team for their efforts in conducting the event, and my hearty congratulations to all the winners." 

Share article