Recently while discussing with colleague regarding device
regulations, I realized much is not know about this topics. And decided to share my learnings via my blog to open a dialogue and learn more.
1.
What is medical device?
It is any instrument which is used in
diagnosis, prevention, monitoring, prediction, prognosis, treatment,
alleviation of disease ,injury or disability. Primarily it is an agent which
does not alter or work on
pharmacological, immunological or metabolic systems of human body, but
which assists this systems in its function.
Let's look at key points mentioned in EU-MDR for monitoring safety of medical devices (European Union's Medical Device Regulation document).
What is combination product?
21 CFR 3.2 (e) Definitions
(1) A product comprised of two or more regulated components,
i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic,
that are physically, chemically, or otherwise combined or mixed and produced as
a single entity
(2) Two or more separate products packaged together in a
single package or as a unit and comprised of drug and device, device and
biological, or biological and drug product. [single entity]
(3) A drug, device, or biological product packaged
separately that according to its investigational plan or proposed labeling is
intended for use only with an approved individually specified drug, device, or
biological product where both are required to achieve the intended use.
[cross-labeled ]
· 1. Reporting post market surveillance of serious incidents and field safety corrective actions through the electronic system:
- any serious incident involving devices made available in EU, except expected side-effects which are clearly documented in the product information and quantified in the technical documentation
- any field safety corrective action in respect of devices made available in EU (includes actions from third country if the reason for the field safety corrective action is not limited to the device made available in the third country).
- All serious related incidents no later than 15 days after MAH (Marketing Authorisation Holder*) become aware of the incident.
- All serious related incident which pose serious public threat no later than 2 days after MAH become aware of the incident.
- Serious related death incident, no later than 10 days after MAH become aware of the incident.
- Inform field safety corrective actions in same timeframe as above before implementing them except in case of urgency when it can be notified after implementing.
- Serious incidents and field safety corrective action which are identified and documented or a implemented and are common they may be submitted as periodic summary reports instead of individual serious incident reports, after consultation with the competent authorities.
MDR Report Requirements:
5-Day MDR Report, described in 21 CFR 803.53(a), which
requires a MDR to be filed no later than five business days following the occurrence
of an event that necessitates remedial action to prevent an unreasonable risk
of substantial harm to the public health
30-Day Device Malfunction Report, described in 21 CFR
803.20(b)(3)(ii), which must be filed no later than 30 days after receipt of a
report of the malfunction of a device; this requirement applies only to certain
permanently implantable, life-supporting or life-sustaining medical devices
2. Recording and reporting of adverse events that occur during clinical investigations:
The sponsor shall fully record all
of the following:
- adverse event of a type identified in the clinical investigation plan as being critical to the evaluation of the results of that clinical investigation;
- any serious adverse event;
- any device deficiency that might have led to a serious adverse event if appropriate action had not been taken, intervention had not occurred, or circumstances had been less fortunate;
- any new findings in relation to any event referred above.
3. Other documents required:
- Post market surveillance plan (PMCF) is necessary except for custom-made device and is part of technical documentation.
- Clinical evaluation report is required
- PSUR required for class IIa, class IIb and class III devices. For class IIb and class III devices update the PSUR at least annually. For class IIa devices update the PSUR when necessary and at least every two years. For class III devices or implantable devices, submit PSURs as specificed with other assessment documentation during registration. For devices other than mentioned, PSURs should be made available upon request of competent authorities (CA).
- Trend analysis is required: any statistically significant increase in frequency or severity of non serious or listed side effects that can alter benefit-risk analysis. The MAH should inform such to competent authorities and also mention how to manage it.
- Field safety notices: Report containing UDI,SRN and field safety corrective action prepared by MAH and submitted to HCP and users after approval form CA.
- RMP ( risk management plan) for each device is required.
- For implantable devices and for class III devices, other than custom-made or investigational devices, the manufacturer shall draw up a summary of safety and clinical performance (equivalent to SmPC) to the public via Eudamed. This document should have UDI-DI and SRN if available other content remains same as of SmPC for drugs. This document should be made available on Eudamed (European database on medical devices).
- . * Also include manufacturer/distributors.
- Having a Unique Device Identification (UDI) system in place which allows to trace the device throughout the system.The UDI shall be used for reporting serious incidents and field safety corrective actions .
- SRN (Single Registration Number) generated from electronic database by Competent Authority while registering device for MAH
- Eudamed is used for maintaining registration, manufacturer details,clinical investigation,certificates,pharmaocivgilance etc by Member States, notified bodies, economic operators and sponsor.
- ‘incident’ means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect
- ‘serious incident’ means any incident that directly or indirectly led, might have led or might lead to any of the following:
(a)the death of a patient, user or other person,
(b)the temporary or permanent serious
deterioration of a patient's, user's or other person's state of health,
(c)a serious public health threat;
(d) any of the above
5. Regulatory representative:
- a diploma, certificate or other evidence of formal qualification in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices;
- four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
- at least two years of professional experience within a relevant field of manufacturing.
- Micro and small companies do need to have this person within their organisation but have a person on contract permanently and continuously at their disposal.
References:
https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32017R0745&from=IT#d1e1058-1-1
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