MDR 2017/745 | EU Medical Device Regulation

The Medical Device Regulation (MDR) was published in the European Union (EU) Official Journal in April 2017 and entered into force on May 26^th, 2021, with a transition period of 3 years before it became mandatory (May 26^th, 2024). Since then, the transitional period for certain MDD (Medical Device Directive) products has been extended according to the amendment to Regulation (EU) 2017/745:

• May 26^th, 2026 specifically for Class III implantable custom-made devices.
• December 31^st, 2027: for higher-risk devices, including class III medical devices and class IIb implantable medical devices; with the exception of sutures, staples, dental fillings, orthodontic appliances, screws, wedges, plates, wires, pins, clips and connectors.
• December 31^st, 2028: for medium and lower-risk devices, including class IIb devices (other than those mentioned above), IIa and I.

It's crucial to note that this extension comes with certain conditions. Only devices deemed safe, and for which manufacturers have already taken substantive steps –as applying to a Notified Body to transition to the rules outlined in the Medical Devices Regulation, will benefit from the additional time. The appropriate Surveillance must be guaranteed for the devices.

The application of the extended transition period is subject to several conditions, such as:

• The devices must continue to comply with Directive 93/42/EEC, as applicable. This condition is already part of the current Article 120(3) MDR.
• The devices do not undergo significant changes in the design and intended purpose. This condition is already part of the current Article 120(3) MDR.
• The devices do not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health. The concept of “unacceptable risk to health and safety” is set out in Article 94 and 95 of the MDR.
• No later than 26 May 2024, the manufacturer has put in place a quality management system (QMS) in accordance with Article 10(9) of the MDR. This condition aims to ensure that manufacturers gradually move towards full compliance with the MDR requirements.
• No later than 26 May 2024, the manufacturer, or its authorised representative, has lodged a formal application under the MDR.
• No later than 26 September 2024 the notified body and the manufacturer have signed a written agreement.

Key changes with the new MDR

The aim of the new MDR 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:

• More strict 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]

The Amending Regulation (EU) 2023/607 allows the MDD certificates to be recognised as valid beyond the dates indicated on the certificate if certain conditions set out in the Amending Regulation are met.

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.

Useful Resources

• Best Practice Guidance for the Submission of Technical Documentation under MDR
• IMNB AB & IMNB UK Ltd Declaration of Impartiality 2023 -2024
• European Commission - Medical Devices
• Intertek Medical Notified Body Standard Fees