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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.

|Aug 7|magazine7 min read

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. 
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