New EU MDR 2017/745

The long journey which has started in 2012 has finally come to an end and the new European Medical Devices Regulation (MDR) has been published in the Official Journal of the European Union. The Regulations will enter into force on May 25th, 2017 and the date of application has been announced as May 26th, 2020,

The MDR 2017/745 will replace the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC), whereas 2017/746 will be replacing 2017/746.

Manufacturers will have to deal with many new requirements such as;

Additional essential requirements,

New classification rules,

Detailed requirements for market surveillance (such as CER, PMCF, PMS, PSUR)

Amanog many others. A long and detailed transition plan will be needed for the most of the manufacturers in order to update their technical documentation and processes to meet the new requirements.

This long awaited text which addresses concerns over the assessment of product safety and performance seems to change the structure and players of the European Medical Device Market dramatically.

In order to have detailed information about the new requirements for your product group and set up an effective transition plan please contact us at bizesorun@13485.info

The countdown already started;