SECTION 2: KEY CHANGES UNDER MDR

Notified Bodies

Notified bodies play a significant role in helping medical device manufacturers bring new products to the EU market. Their primary responsibility is to conduct conformity assessments and grant CE certificates for devices. This involves auditing the manufacturer’s quality management system (QMS) and reviewing the technical documentation for the different classes of devices.

To issue CE certificates, notified bodies must be recertified and designated according to the new MDR. The goal is to identify the notified bodies that are truly qualified to ensure the safety and effectiveness of the products that they are evaluating. Starting on November 26, 2017, notified bodies were able to submit applications to become designated under the MDR. A complete listing of the notified bodies that are officially designated is maintained on the NANDO (New Approach Notified and Designated Organizations) database.

Under the MDR, notified bodies will take on more responsibility in enforcing regulations through annual on-site assessments as well as unannounced audits of manufacturing processes, subcontractors, and suppliers.

The number of notified bodies has decreased significantly due to the new designation requirements³. This will most likely impact manufacturers’ timelines for product certification as resources become more stretched.

Medical Device Classifications

Classification of medical devices is regulated by Annex VIII of the MDR. This classification system is based on the risk that the device poses to patient safety along with the following parameters:

• Duration of use (i.e., how long the device is in contact with the patient/user)
  • Transient: Intended for continuous use for less than an hour
  • Short-term: Intended for continuous use between an hour and 30 days
  • Long-term: Intended for continuous use for more than 30 days
• Whether the product is invasive or noninvasive
  • Invasive devices enter the body in whole or in part, either through an opening of the body or through the surface of the body
  • Noninvasive devices do not enter the body through any opening or surface of the body itself
• Whether the device is active or not
  • Active devices need a source of energy to work

Devices are classified as either Class I, IIa, IIb, or III:

Class III devices pose a high risk to patients. They are invasive and are intended to either support human life or prevent impairment of human health. Medical devices in this category require a conformity assessment by a notified body. Examples include pacemakers and prosthetic heart valves. Approximately 2% of devices in the EU market are Class III devices.

Class IIb devices pose a medium to high risk to patients. They are mostly invasive and may be installed in the body for more than 30 days. Medical devices in this category require a conformity assessment by a notified body. Examples include infusion pumps, ventilators, dialysis machines, and intensive care monitoring equipment. Approximately 8% of devices in the EU market are Class IIb devices.

Class IIa devices pose a medium risk to patients. They are typically invasive and are installed in the body for less than 30 days. Medical devices in this category require a conformity assessment by a notified body. Examples include hearing aids, ultrasonic diagnostic equipment, and catheters. Approximately 20% of medical devices in the EU market are Class IIa devices.

Class I devices are mostly noninvasive and pose a low risk to patients. Devices in this category are divided into the following subclasses:

• Class I: Products are non-sterile or have no measuring function (e.g., wheelchairs, hospital bed, bed pan)
• Class Is: Products are delivered sterile and must be either transported in a sterile condition or sterilized upon receipt (e.g., sterile gauze, personal protection kits)
• Class Im: Products have a measuring function (e.g., stethoscope, thermometer, weighing scale)
• Class Ir: This is a newly added subclass under the MDR that refers to reprocessed or reused products (e.g., surgical instruments and endoscope)

Approximately 70% of devices in the EU market are Class I devices.

The route in which a device obtains its CE Mark (i.e., Annex IX, X, or XI) is determined by its classification.

Conformity assessment routes:

• Annex IX (QMS and technical documentation) is used when a full QMS is implemented by the manufacturer. A review of technical documentation is also required with or without the issuance of a certificate.
• Annex X (type-examination) is used when a manufacturer wants to certify a device based on a representative sample. A notified body examines and/or tests the representative sample and associated technical documentation to determine if the device meets MDR requirements.
• Annex XI (product conformity verification) is used in association with Annex X or in combination with technical documentation for low-risk devices.

Under the MDR, the following medical devices have been reclassified to a higher risk category:

In addition to classification changes, the MDR (Annex XVI) has introduced new manufacturing and surveillance requirements for these previously unregulated devices:

• Contact lenses
• Implants for cosmetic or anatomical modification
• Facial and other dermal or mucous membrane fillers
• Liposuction, lipolysis, or lipoplasty equipment
• Lasers and intense pulsed light equipment for skin resurfacing, tattoo or hair removal, or other skin treatment
• Equipment intended to modify neuronal activity in the brain