EMIS Health was required to register with the MHRA as a manufacturer of medical devices. For all new development going forward, EMIS Health is required to consider if the functionality qualifies as Software as a Medical Device (SaaMD).
The clinically created forms functionality within the Online Triage product has been identified as qualifying for SaaMD.
The purpose of this support content page is to give further information with the process of CE marking which we have applied to the Online Consult clinically authored forms.
The manufacturer has the following responsibilities for qualifying for SaaMD:
- Undertake a conformity assessment for the product, identifying which Directive(s) are in scope
- Set up a product-specific Technical File (which must be maintained for life of the product)
- Prepare and issue a Declaration of Conformity (DoC)
- Apply CE marking to the product and relevant documentary material, e.g. instructions for use, packaging, marketing material and supporting literature
- There are general rules for the application of the CE mark which must be followed, e.g. CE mark must not be covered up. Penalties apply.
Software as a Medical Device (SaMD)
The Medical Devices Directive (93/42/EEC) was amended in 2007 to clarify software as being in scope for a medical device:
- As part of a medical device, e.g. blood pressure monitor
- Standalone software as a medical device (SaaMD) in its own right
- SaaMD is active devices, however, qualify under Directive 93/42/EEC. Compliance expected by March 2010.
- Examples include decision support software, digital clinical calculators and patient monitoring systems/software
- Directive 2007/47/EC (amendment to) 93/42/EEC
What qualifies as a Medical Device?
- Data alone is not a medical device – only when it becomes software
- Must have a medical purpose to qualify as a medical device:
- Individual patients (patient-specific score / alert)
- Clinical purpose (diagnosis, treatment)
- Expert function (calculator, algorithm)
All software classed as active devices (requires a power source) therefore Class 1 – currently
Online Consult has elements which qualify as SaaMD, these are for a Clinical purpose, patient-specific, expert function. Therefore we have CE marked the patient forms which are authored by the EMIS clinicians, as these contain algorithms which direct patients to different outcomes based on their symptoms and responses to questions.
We have not CE marked links to information or signposting, as this is no different to information already available on patient.uk
- Key concept in medical device regulation is ‘intended use’
- Manufacturers must stipulate the intended uses purposes of the device to be marketed – and foreseeable misuses
- No other use may be labelled/marketed
- Cited uses and benefits must be supported by evidence:
- Clinical evaluation
- Technical documentation and version control must match intended use.
Clinical Evaluation & Performance
Clinical evaluation is a mandatory requirement of the Medical Device Directive compliance. The following is required:
- Review of the existing evidence/literature for equivalent / similar devices, relevant standards and published evidence surrounding clinical benefits, known hazards and incidents
- Analysis of device testing, first of type /early adopters, trials and evidence from safety and performance
- Justification of clinical benefits / intended use.
- Links to the overall safety case.
Clinical Safety Case Report
This is a single document collating evidence with links to the following evidence:
- Product description / intended purpose
- Hazard log embedded and evidence for mitigation discussed
- Test requirements and evidence
- Instructions for use and where to find these
- Clinical evidence
- Post Marketing Surveillance
- Clinical Incident Management Process
- Essential Requirements satisfied
- Clinical Assurance Statement / DoC
Declaration of Conformity (DoC)
The organisation is required to make a declaration of conformity (DoC), this involves the following:
- Manufacturer (self-certification) or Notified Body (certification following audit) legal Declaration of Conformity (DoC) to an EU Directive and harmonised standards
- Drawn up based on:
- Technical File review
- Quality Assurance audit (various approaches determined by the classification of the device)
- Must stipulate:
- Device name, version number and classification details
- Manufacturer details
- Details of the auditing body or manufacturer appointed Regulatory Affairs Professional
- Date of declaration and date the CE mark was first affixed to the device
- The EU Directive and harmonised standards.
- DoC generally valid for 5 years, however, Technical File must be maintained continuously and for life.
This is the final stage and should only take place once the DoC has been created
- Product launch / splash / about screen
- User interface where the component appears
- Instructions for use page in Support Centre website / local website / within the app
CE Marking in the Online Consult Product
The following section explains the locations within the Online Consult & Patient Access will be located in the product.
It is only the clinically authored forms that have been CE marked. This includes the following areas of the Online Consult product:
- Private View of the clinically authored forms:
2. Public View of the clinically authored forms from a search:
3. Public View of the clinically authored forms from the start page:
4. Public View of the clinically authored forms when completing a clinically authored form:
5. The Online Consult form document sent from the Online Consult product:
7. Public View of the clinically authorised forms (Patient Access):