Keeping up-to-date with Europe’s medical device regulation

The European Union’s new Medical Device Regulation (MDR) 2017/745 came into force on May 26th, 2017, superseding Medical Device Directive (MDD) 93/42/EC. This began a three-year transition period, meaning all new devices, their manufacturers and other stakeholders in the field must meet the requirements of the MDR by May 26th, 2020.

During the transition period Notified Bodies (NB) may grant device certification according to the MDD. The certificates are valid for a maximum period of five years, until May 27th, 2024, unless the certified product undergoes significant changes. This does not include certificates issued according to Annex IV, which must expire by May 27th, 2022.

Current NB designations will remain valid until the Directive expires. Following this, they must continue the surveillance of the certificates they have granted until the end of their validity. Applications for NB designation according to MDR are currently being processed, with the procedure expected to take up to a year. SGS Fimko aims to be among the first MDR-accredited NBs.

MDR introduces a number of changes, including:

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

For manufacturers, harmonised standards may be 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) – an abbreviation describing the date when an older edition of a standard can no longer be used to demonstrate compliance. Currently there are no harmonised standards for MDR, but state-of-the-art standards can be applied with caution.

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.

Moving to an updated standard requires collaboration between the testing laboratory and the client. Each device must have its future usage environment and, among other requirements, essential performance, defined to ensure it is maintained during testing.

Stakeholders must also consider which functions will be monitored during testing and what is the definition of a situation where performance no longer meets requirements.

Manufacturers are advised to start considering and documenting these matters immediately.