Classification of Medical Devices – European Regulations...

Information & Training. | Medical Devices.

The classification of medical devices in Europe is governed by Annex IX of the Medical Devices Directive 93/42/EEC.

The first stage in any classification process is to ensure that your product is indeed a medical device and comes under the rules of the relevant European Directive. To be classed as a medical device, the medical device needs to have a medical purpose and the primary mode of action will typically be physical. Additionally, if the medical device also has a pharmaceutical property, e.g. drug eluding stent, where there are both medical device and pharmacological properties, you need to determine the “primary purpose” of the product. The “primary purpose” of the product needs to be the medical device aspect, in order for it to be classified as a medical device. If the “primary purpose” of the product is pharmacological, then the product will not be classified under the medical device directives.

Once you have confirmed that the product is indeed a medical device, the next step is to determine what class does it belong to?

Medical devices are classified in accordance with 4 risk groups as follows:

Classification of Medical Devices per European Medical Device Directives.

FDA Medical Device Classification. The FDA approach to Medical Device Classification.
EU Medical Device Regulation and Classification (per MDD’s).
^New European Medical Device Regulations (MDR’s). MDR Classification. MDR General Safety requirements.
Current Good Manufacturing Practices. QSR’s. General requirements of the QSR’s.
Quality System requirements to maintain compliant Validations.
Medical Device Process Validation. Validation requirements. Protocol development. IQ. OQ. PQ.
Medical Device Software Validation.
Medical Device Design Validation.
Electronic Signature, Electronic Records.
Life Cycle Approach to Validation.
Risk Identification. Documentation. DHR’s. DMR’s.
Etc. Etc. …
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• Class I – low risk
• Class IIa – medium risk
• Class IIb – medium risk
• Class III – high risk

Eighteen rules are outlined in Annex IX of the Medical Device Directive and related regulation which outline the principles to be applied for the classification of medical devices.

The eighteen rules are subdivided into four groups as follows:

i) Non invasive devices
ii) Invasive devices
iii) Active devices
iv) Special rules

For example under “non-invasive devices” above, four rules named “Rules 1, 2, 3, 4” apply. These rules are as follows:

Rule 1: All non-invasive devices are in Class I, unless one of the other rules applies.

Rule 2: All non-invasive devices intended for channelling or storing blood, body liquids or tissues, liquids or gases for the purpose of eventual infusion, administration or introduction into the body are in Class IIa.

Rule 3: All non-invasive devices intended for modifying the biological or chemical composition of blood, other body liquids or other liquids intended for infusion into the body are in Class IIb.

Rule 4: All non-invasive devices which come into contact with injured skin.

– are in Class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates,
– are in Class IIb if they are intended to be used principally with wounds which have breached the dermis and can only heal by secondary intent
– are in Class IIa in all other cases, including devices principally intended to manage the micro-environment of a wound.

Note: The above are not the full extent of the classification rules.

The rules for classification of medical devices in Europe have been developed based on the following considerations:

• Duration of contact with the patient
• Degree of invasiveness
• Anatomy affected by the use of the device
• Active or non-active device

Re: “duration”, the following are indicative timelines:

• Transient

• Short Term: ≤ 30 days

• Long Term: > 30 days

In addition, the “intended purpose” is a critical consideration and will be a key aspect of a Risk Assessment which will need to be performed on the intended (and potential for un-intended use) of the device.

The classification of medical devices in Europe, is well defined and is clearly a critical aspect of full regulatory compliance with the EU Medical Devices Directive 93/42/EEC.

Information & Training.

Medical Device:

- - Validation. Classification. Regulation. Requirements. Current best practices.
  - FDA cGMP’s. EU MDR’s / MDD’s.
  - FDA Medical Device Regulation. Outline of the FDA regulatory requirements.
  - FDA Medical Device Classification. The FDA approach to Medical Device Classification.
  - EU Medical Device Regulation and Classification (per MDD’s).
  - ^New European Medical Device Regulations (MDR’s). MDR Classification. MDR General Safety requirements.
  - Current Good Manufacturing Practices. QSR’s. General requirements of the QSR’s.
  - Quality System requirements to maintain compliant Validations.
  - Medical Device Process Validation. Validation requirements. Protocol development. IQ. OQ. PQ.
  - Medical Device Software Validation.
  - Medical Device Design Validation.
  - Electronic Signature, Electronic Records.
  - Life Cycle Approach to Validation.
  - Risk Identification. Documentation. DHR’s. DMR’s.
  - Etc. Etc. …
  - Information & Training presentation >>>