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The European Union’s new Medical Device Regulation (MDR) 2017/745 came into force on May 26, 2017.

IMAGE: The EU’s New MDR: Changing Requirements for Medical Devices

It will supersede the current Medical Device Directive, 93/42/EC, following a three-year transition period.

In practice, this means that all new devices, their manufacturers and other stakeholders in the field must meet the requirements of the MDR from May 26, 2020.

Transition Period

During the transition period, Notified Bodies may grant devices certification consistent with the Directive, but valid for no more than 5 years. If the certified products do not undergo any significant changes, their certification may remain valid until May 27, 2024. However, certificates issued according to Annex IV are an exception to this rule and will expire by May 27, 2022.

Current Notified Body designations will remain valid until the Directive expires. Despite the expiration of the Directive, Notified Bodies must continue controlling the certificates they have granted throughout their validity. Applications for a Notified Body designation according to the new Regulation are currently being processed. The designation procedure is expected to take up to a year, with SGS Fimko aiming to be one of the first MDR-accredited Notified Bodies.

What Does MDR Change?

MDR introduces several changes that manufacturers and stakeholders should be aware of:

  • An expansion to the definition of a medical device to include products used for the prediction of disease and for the cleaning, disinfection or sterilization of medical devices. Products that do not have a medical use but that must be controlled for safety reasons are now included as a new group. These include, for example, cosmetic contact lenses, cosmetic implants, electromagnetic brain stimulation devices, etc. The Commission has retained the right to update the list as required
  • Separate duties have also been defined for importers and distributors. In practice, the manufacturer must prepare for this through its own agreements
  • MDR also requires all medical device manufacturers to have a quality system in place, irrespective of the risk class of their devices, but, as is the case currently, a Notified Body will only assess manufacturers of products with a higher risk class
  • Manufacturers must have a designated person responsible for regulatory compliance and they must meet defined competence requirements. For large manufacturers, this person must be an employee; for small manufacturers, the person can be a consultant but shall be permanently at the manufacturer’s disposal
  • Each device must have a Unique Device Identification (UDI) that should be compatible with the FDA system. This will require an update to the current Eudamed database
  • MDR has replaced essential performance with the phrase, “general safety and performance requirements”. These have expanded considerably, and the requirements have been clarified
  • Requirements concerning a product’s technical file have been expanded and clarified. In the future, it will be worthwhile compiling the technical file for new products in accordance with Annex II of the MDR
  • Requirements for the product and the accompanying instructions and marketing material have been specified. Particular attention has been given to misleading claims, which have been expressly forbidden
  • The current 18 classification rules have been replaced with 22 rules. Essential changes have only occurred in relation to software classification
  • Prior guideline documents are now practically incorporated in legislation. For example, provisions concerning the clinical evaluation of a product are now considerably more detailed and binding

Deadlines for Harmonized Standards

Manufacturers may use harmonized standards as the easiest way to demonstrate compliance with the requirements of the law. Different editions of the standards are associated with their DOCOPOCOSS (Date of Cessation of Presumption of Conformity of Superseded Standard). This abbreviation describes the date when an older edition of a standard can no longer be used to demonstrate compliance.

Stakeholders should be aware that, in relation to medical devices, the DOCOPOCOSS dates for two standards have either passed or are approaching cessation:

  • Main standard EN 60601-1:2006 expired on December 31, 2017. Products launched on the market after this date must meet the requirements of the newer standard EN 60601-1:2006 + A1:2013. In practice, this involves either re-testing or at least a GAP analysis to demonstrate the product also meets the requirements of the updated standard edition
  • EMC standard EN 60601-1-2:2007 will expire on December 31, 2018. As the newer standard EN 60601-1-2:2014 has a significant number of new measurements and requirements, re-testing is the only practical option for manufacturers

It is important to note that moving to an updated standard requires collaboration between the testing laboratory and the client. For each device, the future usage environment and, among other requirements, the essential performance must be defined to ensure it is maintained during testing. They should also consider which functions will be monitored by the person carrying out the testing and what is the definition of a situation where performance is no longer meeting the requirements.

Manufacturers are advised to start considering and documenting these matters right away, if they have not already started.

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To learn more about product testing and the EU’s new Medical Device Regulation, contact:

Seppo Vahasalo
Chief Technical Manager
t: +358 9 6963 450