MDR and UKCA Services for Orthopedic Medical Devices

Orthopedic devices cover a broad spectrum, ranging from implants and instruments to rehabilitation tools. To ensure that the EU Notified Body or UK Approved Body is qualified to review a specific device, devices are categorized and grouped based on the intended use or technologies employed in the device. For the convenience of the manufacturer, we use a single coding system for both the EU and the UK. The devices are allocated codes based on the publicly accessible EU MDR code list from commission implementation regulation (EU) 2017/2185 of Nov 23, 2017, and guidance from the Medical Device Coordination Group Document MDCG 2019-14.

For orthopedic devices, these codes may include:

• MDN 1102: non-active osteo- and orthopedic implants. These include:
• Joint (hip, knee shoulder, ankle) and spinal disc replacements
• Bone graft substitutes for orthopedic and maxillofacial use
• Sutures and suture anchors
• Orthopedic surgery staples
• Spacers
• Ligament reconstruction products
• Osteosynthesis devices, such as orthopedic nails, screws, and plates
• MDN 1205: non-active, non-implantable orthopedic and rehabilitation devices. It includes devices like orthoses, crutches, and wheelchairs, which are crucial for supporting patient mobility
• MDN 1208: non-active, non-implantable instruments such as forceps, clamps, scalpels, reamer, drill bits, mallets, bone spoons, curettes, retractors, elevators, burs, spatulas, and patient-specific instrumentation (PSI). It also covers non-active devices used in conjunction with arthroscopic equipment, such as arthroscopy trocars

To support efficient conformity assessments, devices are also grouped using the European Medical Device Nomenclature (EMDN) for the EU, or the Global Medical Device Nomenclature (GMDN) in the UK, to identify and categorize orthopedic devices that can be assessed together.

Under the EU and the UK regulations, medical devices are classified into classes I, IIa, IIb, and III, based on their intended purpose and inherent risks. The classification of an orthopedic device may be determined by the application of one or more of the classification rules outlined in these individual regulations. For CE marking, classification rules are listed in Annex VIII of the EU MDR and the UKCA Classification rules are listed in Annex IX of the UK MDR. This can lead to slight differences in the classification in the EU and the UK.

For the EU MDR, rules 1, 6, 7, 8, 14, 18 and 19 are most relevant to orthopedic medical devices. For example:

• Non powered wheelchairs are classified as Class I under Rule 1
• Reusable manual orthopedic reamers are Class I under Rule 6
• Spinal needles and cord retractors are Class III under Rule 6
• Arthroscopy trocars are Class IIa by Rule 7
• Artificial ligaments are Class IIb under Rule 8
• Non-absorbable maxillo-facial implants are Class IIb under Rule 8
• Joint replacements are class III under Rule 8
• Biodegradable bone cements or fracture fixation screws are Class III under Rule 8
• Devices incorporating medicinal products, such as bone cement with antibiotics or silver coated hip implants, are Class III under Rule 14
• Bone graft substitutes manufactured utilizing tissue are Class III under Rule 18
• Bone fillers containing nanomaterials are Class III, and fixation screws/plates with a strongly bound nano-coating are Class IIb, as per Rule 19

Generally low-risk Class I devices are ‘self declared’ by the manufacturer. However a Notified Body and/or UK Approved Body needs to be involved in the assessment of Class I devices that are sterile, or have a measuring function. Additionally, the EU MDR also requires Notified Body involvement in the assessment of Class I reusable devices.

The EU MDR introduces the concept of ‘well-established technologies’ (WET) where specific requirements of the regulations may not apply to an exempt list of devices, including orthopedic screws, wedges, plates, wires, pins, clips, and connectors. This can reduce the conformity assessment activities required for well-established devices, so it is important to be aware of the latest interpretation of ‘well-established’ and the list of exemptions.

In the EU, Custom Made Class III implantable orthopedic devices require conformity assessment from a Notified Body that is limited to an audit of the manufacturer’s quality management system. We can support you with such applications.

In the UK, Custom-made devices are not required to be UKCA marked. However, they must meet the relevant provisions of the UK MDR 2002 that apply to them. In addition, manufacturers of custom-made devices do not require the intervention of a UK Approved Body.