Medical Device Regulation: what is it about?
The EU’s Medical Device Regulation (MDR) is a hot topic in healthcare and a major concern for companies since 2017. It was officially published on 5th May 2017 and came into effect on 25 May 2017. The MDR is supposed to replace the current EU documents, Medical Device Directive (93/42/EEC) and Directive on active implantable medical devices (90/385/EEC).
Manufacturers of currently approved medical devices were given a transitional period of 3 years, till the 26th of May 2020, during which they had to reorganize the operations to meet the requirements of the MDR. An amendment to the MDR was adopted on 24 April 2020 by European Commission, which postponed the application of most of its provisions by one year, until 26 May 2021. However, certain devices that meet special requirements can be granted permission to extend the transition period till the 26th of May 2024.
Post-market surveillance: what’s new
Articles 82 through 86 and Annex III of the EU MDR describe the requirements for a post-market surveillance system (PMS), making PMS mandatory, and those manufacturers who want to remain in compliance with new MDR are obliged to re-organize the PMS system and Vigilance System following the new requirement.
The PMS process is the collection and analysis of the data that comes from the various sources according to Annex III and is carried out according to a PMS plan for each product. There are various purposes for which this data can be used, such as:
- Update of the benefit-risk determination and improvement of the risk management;
- Update of the design and manufacturing information, the instructions for use and the labeling;
- Update of the clinical evaluation;
- Update of the summary of safety and clinical performance;
- Identification of needs for preventive, corrective or field safety corrective action;
- Identification of options to improve the usability, performance and safety of the device;
- Contribution to the post-market surveillance of other devices (when relevant);
- Detection and reporting of trends.
Risk management requirements for post-market surveillance for medical devices
With PMS becoming a duty for medical device manufacturers, the effective risk management system becomes a priority as well as one of the three basic elements that ensure compliance and safety, alongside with PMS and clinical evaluation (see Image 1).
According to the MDR, manufacturers are expected to provide evidence of a risk management plan created for the whole lifecycle of products. Such plans should be used for tracking and reducing any potential hazards and ensuring the safety of the devices.
The MDR references to the following risk-related key notions:
- Risk is defined in Article 2 as “the combination of the probability of occurrence of harm and the severity of that harm”;
- Benefit-Risk Determination is defined in Article 2 as “the analysis of all assessments of benefit and risk of possible relevance for the use of the device for the intended purpose, when used in accordance with the intended purpose given by the manufacturer”;
- General obligations are defined in Article 10 in the following way: “Manufacturers shall establish, document, implement and maintain a system for risk management as described in Section 3 of Annex I”;
- The Quality Management Systems shall address the following matter – “risk management as set out in in Section 3 of Annex I”
The following requirements by the MDR should be addressed in order to ensure compliance and correct benefit/risk management:
- establish and document a risk management plan for each device;
- identify and analyse the known and foreseeable hazards associated with each device;
- estimate and evaluate the risks associated with, and occurring during, the intended use and during
- reasonably foreseeable misuse;
- eliminate or control the risks referred to in point (c) in accordance with the requirements of Section 4;
- evaluate the impact of information from the production phase and, in particular, from the post-market
- surveillance system, on hazards and the frequency of occurrence thereof, on estimates of their associated risks, as well as on the overall risk, benefit-risk ratio and risk acceptability;
- Amend control measures if necessary.
What else is there to keep in mind?
In 2019, a new ISO 14155:2018 draft will be published and will contain changes on pre- and post-market clinical investigations for medical devices. It is expected that the new, third revision will contain more explicit and thorough indications on risk management. Additionally, it will be closely tied to the risk management requirements outlined in ISO 14971.
Other significant changes in the new ISO 14155:2018 draft include:
- Guidance on clinical quality management, clinical investigation audits and ethics committees
- Risk-based monitoring requirements
- Registration of clinical investigations in publicly accessible databases
- Clarifications on how ISO 14155 requirements apply to each stage of clinical development
- Annexes relating ISO 14155 to the European Medical Devices Regulation, and to the Medical Devices Directive (MDD) and Active Implantable Medical Devices Directive (AIMDD).
Useful Medical Device Regulation terminology
- MDR – Medical Device Regulation
- PMS – Post Market Surveillance
- PIP- Poly Implant Prosthesis
- MDD – Medical Device Directive
- FDA – Food and Drug Administration
- PMCF- Post Market Clinical Follow-up
- CER – Clinical Evaluation Report
- RM – Risk Management
- PSUR- Periodic Safety Updated Report
- PMSR – Post Market Surveillance Report
- SSCP – Summary on Safety and Clinical Performances
- SAE – Serious Adverse Event
- IFU – Instruction For Users
How can Arithmos help you to ensure MDR compliance?
Are you looking for technological solutions to facilitate clinical trials and adverse events management for your Medical Device products? We offer such solutions as Symphony, flexible and easy to set up EDC system, and Argus BluePrint, pre-validated and pre-configured version of Oracle Safety, that ensure compliance and security of the processes for Medical Device companies. Arithmos, alongside its sister company seQure Life Sciences, can also support companies in a consultative way by making sense of the MDR and analyzing a company’s needs in terms of quality assurance and regulatory compliance. We can support with an initial gap analysis and risk assessment regarding the MDR.
Contact us if you would like to learn more about our Medical Device solutions and we will get in touch with you as soon as possible to set up a call.