New European Union Medical Device Regulation

Table of Contents

What is MDR?

The MDR is the new regulation for medical devices and sanitary products. Its main objective is to establish new requirements for the production and supply of medical devices in European territories while meeting high quality and safety standards.

It appeared in response to the need for updated measures established by the Medical Devices Directive (92/42/EEC) (MDD) and the Active Implantable Medical Devices Directive (90/385/EEC) (AIMDD).

How does this new regulation impact the market?

These changes are in response to new European Union requirements for medical devices.

All actors in the medical device field, from manufacture to use, are obligated to comply with the Medical Device Regulation (MDR) and the InVitro Diagnostic Device Regulation (IVDR). It is important that they are constantly aware of changes to implement them efficiently and quickly.

What are the new requirements imposed by the MDR?

The MDR seeks to modernize the current system in the European Union. Among the new regulations you can find:

A Quality Management System (QMS) compliant with ISO 13485: 2016 is required for devices of all classes, including Class I.

New medical device classifications and system support via conformity assessment.

Registration and communication linked to the authorized notification body through an agreed mandate. Registration in the European Database for Medical Devices (EUDAMED).

Documentation and maintenance of (CE) labeling and Unique Device Identification (UDI).

Post-marketing activities, like implementation of a vigilance system or system for reporting safety incidents and corrective actions.

Medical device manufacturers must have: technical documentation in accordance with Annexes II and III, clinical evaluation in compliance with new requirements, post-market surveillance systems (PMS), liability insurance to cover damages by devices to patients and/or user.

Designate a person responsible for compliance with MDR regulations in the manufacture of medical devices.

New Categorization Format

The new regulation impacts how companies that produce medical devices and sanitary products are categorized. Currently, all devices are divided into four categories:

Non-invasive devices

Invasive medical devices

Active medical devices

Special rules (including contraceptive, disinfectant and radiological diagnostic medical devices).

In the MDR, the categories of medical devices are placed into sub-categories:

Class I: non-sterile or without measuring function (low risk). The MDR dictates that all reusable surgical instruments fit in this class.

Class IIa: medium risk.

Class IIb: medium / high risk.

Class III: high risk.

IVDR: The new role of translation

For the IVDR (InVitro Diagnostic Device Regulation), new measures will also apply. Its implementation date is May 26, 2022. However, manufacturers will have a two-year transition period to obtain their declarations of conformity and, thus, maintain permission to remain in the European market. This new regulation will allow greater applicability to more in vitro diagnostic devices.

Language and translation are paramount in the new regulations. Product instructions should be part of the technical documentation and should be reviewed by the notified bodies along with the package labeling. Once this documentation is approved, the instructions should be available on the manufacturer’s website.

Yet again, language plays a key role in the new changes taking place in the industry. New regulations, accompanied by correct and accurate translations, expand patient access to information about medical devices.

What are the new IVDR requirements?

The IVDR contains several new requirements, including some of the following:

Implementation of a Quality Management System, with Conformity Assessment.

New requirements for CE marking on the device supported by technical documentation.

Performance evaluation and performance studies for IVD devices to complete the CE technical dossier.

Compliance with clinical investigation reporting and post-market surveillance requirements.

Authorized representative responsible for regulatory compliance.

Some things to keep in mind:

After May 26, 2022, products marketed under the InVitro Diagnostic Directive (IVDD) will effectively remain under design freeze until they are recertified by the IVDR.

The IVDR is more stringent with the need to identify the medical condition, target audience, and scientific evidence of validity.

Also, marketing actions present or potentially presentable by the manufacturer, including websites and any social media presence, will be inspected.

At Lexic, we offer quality solutions and services for medical device companies to comply with the EU regulations and requirements mentioned in this article, and many others.

Please contact us if you are looking for a translation partner.