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In May 2020 the new EU medical device regulations MDR and IDVR (first published in May 2017) will go into effect. The new Regulations will now legalise groups of products without an intended medical purpose, listed under Annex XVI, as medical devices. This will provide certain challenges for many manufacturers, with some facing significant delays and others having to pull their products from the EU market altogether.

These restrictions may also lead to challenges for patients as they will be faced with complications in purchasing certain products. Customers will however have the increased benefit of knowing they are better informed on safety and health data for products that are on the market.

Why the change?

The 2017 MDR legislation changes are in response to the growing concern that medical devices and diagnostics up until now have not be controlled tightly enough before being exposed to the public or being used by patients. And with more than 500,000 types of MDV’s and IVD’s on the EU market, and the increased complexity of such products this monitoring is even more essential.

The aim is to enhance patient safety by providing a thorough, in-depth governance framework around the definitions themselves, as well as providing trace-ability for such medical devices.

Under the new regulations manufacturers must ensure they are compliant with the MDR and IVDR.

How to comply:
  • Determine which risk class your product comes under
  • Ensure your product complies with the MDR
  • Where required, carry out and pass a conformity assessment
  • Place a CE mark on product
  • Assign a UDI
  • Submit key information about the manufacturer to the Electronic system

 What legislation changes can be expected from MDR and IVDR?

  • The medical devices definition will be broadened to include cosmetic and non-medical devices such as contact lenses.
  • Manufactures will be required to provide more in-depth clinical data proving their device is fully health and safety compliant.
  • All existing products are required to be recertified.
  • A UDI will be applied so that products can be tracked and furthermore recalled if required.
  • The IVD definition will broaden to include medical devices that predict a patient’s response to treatment.
  • The classification system for IVD’s have been changed from list-based to rule-based.
  • IVD’S classed B, C and D will require assessment and certification by a notified body.

In preparation Manufacturers of currently approved Medical devices have been given a transition period to meet the requirements. To ensure a smooth transition early planning and reviewing for each device is essential. All Manufacturers will be required to appoint at least one Quality Assurance person to take charge of all matters of compliance ensuring regulations are being met with both old and new products.

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