Article: New Extensive Medical Device Regulation to Come Into Effect in 2021

In the new decade, the medical device regulatory landscape will rapidly transform. From the 26th May 2021, EU regulation (2017/745)^[1], will come into effect, changing the classification models used for the storage of medical devices. Originally, the referendums were proposed to be applied on the 26th May 2020. However, to prevent delays in getting key medical devices on the market - given the current pressure on health authorities due to COVID-19 - the application is being postponed by a year. 

The new European regulations include 123 articles and 17 annexes over 175 pages – making it the most comprehensive overhaul since the instigation of the medical device regulatory landscape^[2]. And it is likely that many countries outside the European Union will follow suit soon after.

Four Key New Changes to Medical Device Regulations

- Higher risk medical devices will need to undergo further evaluation tests
- There will be more precise requirements to help maintain correct temperatures during storage and transport
- Every medical device will require a unique UDI (unique identifier)
- Temperatures will need to be monitored throughout the shipping process – with deviations from set standards necessitating reporting

These regulations are already followed to a large degree by distribution and manufacturing companies in the medical industry, across the world. The difference now is that not adhering to them will lead to serious legal ramifications.

The Numerous Benefits of the New Higher Standards

Medical devices are critical to the health and quality of life for millions of people worldwide. Adopting these new regulations will lead to increased safety and more reliable treatments, ultimately for improved patient outcomes. 

At World Courier, evolving our supply chain procedures per new regulations is part of our dynamic compliance process. Meanwhile, ensuring storage, transport and distribution conditions meet and exceed safety and performance requirements set by manufacturers is a feature of our supply chain^[3]. This compliance is now clearly defined in Annex I to ensure logistics providers maintain their adherence.

In 2015, in South Africa, The Medicines and Related Substances Amendment Act 14^[4] brought significant regulatory changes that bear some semblance to the new EU regulations. We at World Courier, implemented the amendment act successfully.  Along with this, demand for a new license arose – which after several audits, was granted to us by the licensing commission due to our supply chain standards.

Medical Devices: Four New Different Risk Classes

- Class I [Low Risk]
- Class IIa [Low-Moderate Risk]
- Class IIb [Moderate-High Risk]
- Class III [High Risk]

With the new European regulation, more clinical data will be collected. Meanwhile, more thorough clinical investigations will also take place^[5]. And medical devices in the market will only be released once they have been brought into conformity with compliance criterias and clinical safety standards.

What This Means for Medical Device Clinical Trials

Requirements for clinical trials will be more rigid and thorough – similarly to the standards required for trials of pharmaceutical products. Trials will require clinical investigation plans – which set out the rationale, objectives, methodology, record-keeping and method of analysis for the investigation – among a larger number of requirements. All the while, devices that were previously considered as auxiliaries to medical devices (accessories for cleaning, disinfection, or sterilization) are now in the scope of the MDR.

Serious Incidents Reclassified

‘Reportable events’ have now been reclassified as ‘serious incidents’. The intention is to ensure that companies do more of their due diligence to actually report these incidents or events. A serious incident includes the death of a patient or user, the deterioration of a person’s health, or a serious public health threat. The higher level of vigilance reporting and post-market surveillance will mean that EU regulators will have access to more data, informing future regulatory changes – in a manner that benefits public health in the best manner possible.

Key Ways to Stay Compliant

- Correctly classify devices against the new risk classification criteria (Annex VIII of the MDR)
- Meet the general safety and performance requirements, including for labeling and technical documentation and quality management systems (Annex I of the MDR)
- Confirm requirements for clinical evidence are met (Annex XIV of the MDR)
- Meet reporting timescales and ensure an annual periodic safety update report is created (Chapter VII, Section 1 and 2 of the MDR)

Stay Compliant with World Courier

For high-value temperature-controlled storage, transport and distribution, use WorldCourier’s MDR compliant service. With over 50 years of innovation, dynamic adherence to medical regulations, we have built supply chain processes that are designed to make your clinical trial a success.

_{[1] Medical devices: EU regulations for MDR and IVDR: https://www.gov.uk/guidance/medical-devices-eu-regulations-for-mdr-and-ivdr
[2] Comparison of the article of the European medical devices directive (93/42/EEC) and the medical devices regulation ((EU) 2017/745: https://www.bsigroup.com/globalassets/localfiles/zh-tw/medical_device/document/bsi-smart-support-mdd-mdr-comparison.pdf
[3] Article 13 – General obligations of importers: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745&from=EN
[4] Medicines and Related Substances Amendment Act 14 of 2015: https://www.gov.za/sites/default/files/gcis_document/201601/39585act14of2015medicinesrelatedsub.pdf
[5] Article 61, Page 55 - Regulation (Eu) 2017/745 Of The European Parliament And Of The Council Of 5 April 2017 On Medical Devices: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745&from=EN}