New MDR and IVDR regulations were approved in March 2017 by the European Council and in April 2017 by the European Council to take full effect in mid 2020. The new MDR combines the requirements of Medical Device Directive (MDD) and the Active Implantable Medical Device Direction (AIMD), and is in direct response to the technical and scientific developments that are quickly shaping the medical device industry.

The new regulations seek to increase medical device safety and effectiveness in the EU Market while addressing weaknesses revealed in the implementation of Medical Device Directives by several medical device manufacturers. The regulations feature several significant changes and, while many medical device manufacturers already have started implementation efforts, this article aims to provide a quick summary of the key changes:

1.    The “medical device” classification

(Article 1, Article 2, Article 22, Article 23, Article 51, Article 52,  Annex VIII, IX, X, XVI)

While the classification system has been retained, rules have tightened and changed for some products, which will result in some devices being reclassified to higher classes. In addition, some devices that were previously exempt from the regulations are now in the scope of the new legislation.

New areas that will be classified as a medical device include:

  • Aesthetic products – colored contact lenses, cosmetic implants, lipoplasty devices, and laser products used for hair removal.
  • Cleaning products – anything used for cleaning, disinfecting, and sterilizing medical devices (e.g., scope disinfector).
  • Conception products (for support or control) – condom, intrauterine device.

2.    Roles of Economic Operators

(Articles 10, 11, 13, 14, 15, 30)

Economic operators including manufacturers, distributors, importers, suppliers, subcontractors, assemblers, and EU Authorized Representatives, all of whom carry responsibility for conformity to the regulations will face major increase in responsibilities. In addition, a person responsible for regulatory compliance must be available within the organization, with expertise in medical devices demonstrable through experience or qualification.

3.     Supply chain traceability and Unique Device Identifiers (UDIs)

(Article 27, Article 87, Article 18, Article 19)

A completely new feature of the Regulations is the system of Unique Device Identifiers (UDIs). This will enhance the identification and traceability of devices. The UDI will allow all stakeholders to access basic information on devices through the European Database on Medical Devices (EUDAMED).


4.     Clinical Evaluation / Postmarket Clinical Follow-up, Clinical Investigations

(Article2, Article 55, Article 61, Annex XIV, Annex XV)

New changes are also tightening the area of clinical investigations and postmarket clinical follow-up. All clinical evidence must be updated for existing medical devices and must be clear, convincing, and publicly available. Clinical justifications based on device equivalence will no longer be easily accepted – in other words the new Regulation is introducing stricter requirements for comparative evaluation.


5.      Periodic Safety Update Report (PSUR) and PMS

(Articles 84, 85, 86, 87, 88, 93)

Under the new regulations associated with vigilance and postmarket surveillance, manufacturers are expected to gather and report information related to safety of medical devices to EU database.

The database will capture registration of devices, accredited Notified Bodies, Certificates, Serious Incidents, Safety and Clinical Performance Reports (SSCP), Periodic Safety Update Reports (PSUR),  Surveillance Activities, Clinical Investigation Data, Unique Device Identification Information (UDI), and Single Registration Information to correlate information from manufacturer, authorized representative, and importer.



The goal of these new regulations is to improve safety, quality and transparency for medical devices across the EU. As latest trends show that regulatory requirements will be tightened manufacturers should fully understand the new regulation and to prepare for the changes ahead.