In today’s world of emerging diseases, in which a new pathogen or virus is discovered on a daily-basis, the medical field is striving to develop its infrastructure & facilities to the maximum extent possible in order to tackle these life-threatening situations.
Since the operational area here is critical, the security and safety criteria or measures which should be considered on each phase of implementation or development shall be stringent. Hence the European Union developed this regulation which is a set of rules that governs the production and distribution of medical devices in Europe.
1. Where is this regulation applicable?
The MDR is applicable to all the EU member states. The manufacturers from outside Europe who wish to sell their medical products within the European Union need to familiarise themselves with the rules and other obligations related to this regulation.
2. Safety first approach:
The regulation implies a lot on developing and maintaining safety requirements, as this is something that is going to have a major impact on human life. Manufacturers must perform a safety risk assessment and must design and develop the devices based on the results obtained from the assessment. There shall be proper procedures in place to evaluate and treat the residual risks in a persistent manner.
3. No compromise on Quality:
One important factor to be considered is to implement a quality management system for the development lifecycle of the medical devices. MDR emphasises on maintaining the quality of the system by mandating the manufacturer to have personnel responsible for managing the quality processes, to have a detailed procedure documented & implemented, an audit to be carried out by a ‘Notified body’, etc.
4. Classification of devices & UDI:
UDI stands for Unique Device Identification. This UDI system shall be followed for all the products that are intended to be placed on the European market, except for the custom-made ones. This will help in the traceability of devices, which will further enhance various phases of post-market surveillance, which could include monitoring, implementing corrective measures, safety related activities etc.
On the top of this, there is another important aspect of classification to be made on these devices, based on different factors such as device’s dependency on sources, devices impact on human body, degree of invasiveness, etc taking into account the vulnerability vs risk factor. These are referred to as the ‘classification rules’ and are set out in Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)¹.
5. Post-market surveillance and technical documentation
The post-market surveillance shall provide a means to allow a comparison to be made between the device & similar products. The plan shall include collection & utilisation of available information, such as feedback and complaints about the products, undesirable side-effects, etc. This shall also incorporate an effective & proactive approach to investigate the complaints received and to analyse the market-based experience collected in order to enhance improvements. The technical documentation which needs to be prepared by the manufacturer shall include all these plans and aforementioned details.
Medical devices are an absolute need when it comes to human life and there is no substitute for them. Like every other good thing, medical devices also have their negatives when it comes to the way of using it. Hence these kinds of regulations act as our coach to play the game safe.
If you wanna learn more about this topic check-out what subject matters experts are saying in this latest webinar: https://youtu.be/cqHnf9dUh-c or get in touch with them to ask any related question.
¹https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745