The EU Medical Devices Regulation (MDR 2017/745)

On April 5, 2017, the EU adopted the Medical Device Regulation, replacing the two existing directives, the Medical Devices Directive and the Active Implantable Medical Devices Directive.

The Medical Device Regulation entered into force on May 25, 2021, after a four-year transition period. This means that the market access framework for all member countries of the European single market changed significantly.

Key changes

The aim of the new Medical Device Regulation was to address some inherent weaknesses in the old directives as well as the swift evolution of science and technology in the field of medical devices. To do so, it introduced several key improvements, among them:

• stricter ex-ante control for high-risk devices via a new pre-market scrutiny mechanism with the involvement of a pool of experts at EU level
• the reinforcement of the criteria for designation and processes for oversight of Notified bodies
• the inclusion of certain aesthetic devices which present the same characteristics and risk profile as analogous medical devices under the scope of these Regulations
• improved transparency through the establishment of a comprehensive EU database on medical devices and of a device traceability system based on Unique Device Identification
• the introduction of an “implant card” containing information about implanted medical devices for a patient
• the reinforcement of the rules on clinical evidence, including an EU-wide coordinated procedure for authorisation of multi-centre clinical investigations
• the strengthening of post-market surveillance requirements for manufacturer
• improved coordination mechanisms between EU countries in the fields of vigilance and market surveillance

_{Source: ec.europa.eu}

Medical devices compliant with the MDD on the market after 26 May 2021 must be compliant with the Article 120(3) of the MDR.

From 26 May 2021:

• The device continues to comply with the Directive.
• There are no significant changes in the design or intended purpose.

Furthermore, the requirements in the MDR related to the following shall apply:

• Post-Market Surveillance [Article 83-86, 92, Annex III]
• Market Surveillance [Article 93-100]
• [Article 87-92]
• Registration of economic operators and devices [Article 31 and 29]

MDR Certification service

Medical Device certification under the Medical Device Regulation MDR (2017/745) is offered through our legal entity Intertek Medical Notified Body AB (IMNB AB), Notified Body Number NB 2862.

The headquarters for IMNB AB is in Stockholm, Sweden. We continue to have our teams based around the globe, including but not limited to North America, China, India, United Kingdom, and Sweden.

If you are a client and have a current MDD certificate(s) with us, these will remain under SEMKO AB NB 0413 until that certificate expires, unless you are specifically notified otherwise.

Basic steps of the new MDR application process

 Fill out the MDR Pre-application form.

Intertek Medical Notified Body does not offer any consultancy services.