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Blockchain is the Answer for EU MDR Traceability Requirements for Medical Devices - Alysidia

January 25, 20210

The advent of cryptocurrency is considered one of the major breakthroughs in the scientific world. The idea of virtual currency and a whole new economic system has slowly become popular across the globe. Among thousands of cryptocurrencies that are present today, Bitcoin is considered as the first cryptocurrency, and it is backed by a technology known as “Blockchain.”

Professionals from other industrial sectors, especially the life-science sector which also includes devices and diagnostics, are fully aware of Blockchain and is worth in traceability of cryptocurrencies. This traceability can also be incorporated into the supply chain of medical devices.

What is Blockchain Technology?

Constitution of Blockchain

Blockchain comprises blocks of encrypted data and operations that are linked together in a digital register. This register contains information of transaction that occurs as peer-to-peer transactions between people of the same blockchain network.

De-centralized Nature of Blockchain
  • The blockchain network is not controlled by any central power, such as a state or government. Each blockchain user can see and maintain the original version of the blockchain.
  • Existing users perform a mutual consensus on making updates in the blockchain. Because of this consensus, no one can alter, change, or corrupt any blocks of data forming the blockchain network.
Prevention from Cyber Attacks

A blockchain network is safe and secure from cyber-attacks due to two possible reasons:

  • Blockchain is a decentralized network and lacks a centralized database. This makes it impossible for any virus or hacker to launch a cyber-attack on the blockchain network.
  • Each blockchain allows a vast majority of people to become its part. These people in turn maintain the integrity of the blockchain network by ensuring proper distribution of the blockchain.
  • Having a large number of people in a blockchain network also makes transactions transparent, as it is necessary to ask for the consent of every blockchain member before making any changes.

Medical Technology and Role of Blockchain

Advancements in the field of medicine require a steady supply of resources. A disturbed supply of these resources can disrupt the ongoing processes. The businesses associated with such fields of life-sciences also require to ensure the integrity of their supply chain as this helps them in

  • Ensuring continuity of their supply;
  • Prevention of launching pirated and falsified products;
  • Identification of defective products and
  • Compliance with regulatory requirements.
How Blockchain Can Maintain Integrity of Medical Supply Chain?

Blockchain can serve to be an effective tool in the maintenance of the integrity of the medical supply chain. For example, it can perform the important role of recording maintenance of supply, manufacturing, and distribution process. This can nullify the need of having large infrastructure designated for the record-keeping process. The record-keeping and maintenance, therefore, becomes easier.

What information can be placed on Blockchain?

A blockchain network which is designated to record information on the medical supply chain can store and monitor information such as

  • Place of production of active substances in a medical device;
  • Place of production of different components of a medical device;
  • Manufacturing locations;
  • Date of shipping;
  • Batch number;
  • Expiry date;
  • Optimum storage temperature and
  • Unique Device Identification (UDI) etc.

With the use of blockchain, any party or person involved in the supply chain can easily determine and update the blockchain ledger. The updated information can include useful information, such as receipts of the product’s shipping and product journey. People involved in the supply chain can access any product’s blockchain using different means (e.g. through bar code printed on the product).

Benefits of Blockchain-backed Supply

Blockchain-backed supply chains can help a manufacturer or business in determining the exact fault which is disrupting the supply chain.  Businesses can make efficient use of blockchain to determine and remove a defective product from circulation.

EU MDR, EU IVDR, and Blockchain

The EU has evolved a lot in terms of its medical device manufacturing industry. Currently, it transitioning from old requirements (EU MDD) to the new ones i.e. EU MDR and EU IVDR. Articles 25 and 27 of EU MDR and Article 22 of EU IVDR have put forward additional requirements of traceability, and incorporating Blockchain to fulfill these requirements can be a better alternative.

Automation and Blockchain

Both EU MDR and IVDR have put their emphasis upon automating the medical device manufacturing industry. Automation measures such as

  • Use of UDI in human-readable and machine-readable form;
  • Use of automatic identification and
  • The use of data capture technology (e.g. QR codes and barcodes) etc. can be used in conjunction with blockchain technology.

The manufacturers who want to include machine and/or human-readable code on the packaging of their product to access the blockchain must comply with local product labeling requirements. Such manufacturers may also require permission from the relevant competent authority to do so.

Accessibility to Blockchain

Whether it is a barcode, UDI, or any other automatic identification tool, Blockchain can easily be incorporated with it. A single bar code or a separate Radio Frequency Identification (RFID) can be used to get access to the blockchain traceability system.

Economic Operators and their Responsibilities

Under the new regulations, economic operators are defined as

  • Manufacturers
  • Authorized representatives
  • Importers
  • Distributors
  • A person who combines CE marked devices and
  • A person who sterilizes CE marked devices.

Under the Article 25 of MDR and Article 22 of IVDR, the above-mentioned economic operators should identify

  • Any economic operator to whom they have supplied a medical device directly;
  • Any economic operator who has supplied them a medical device directly and
  • Any health-institution or health-care professional to whom they have supplied a medical device directly for 10 years, given that the last device covered by the EU declaration of conformity has been placed on the market. In the case of implantable devices, this period extends to 15 years after the device has been placed on the market.
Role of Blockchain for Economic Operators:

An economic operator using a blockchain-based traceability tool can enjoy the following benefits:

  • He can easily get access to the blockchain of a product and provide relevant information to the authorities;
  • He can closely monitor supply-chain which can help in the detection of counterfeit products;
  • He can closely monitor supply-chain to help in quick reporting of adverse events;
  • End-users who have access to the product’s blockchain can confirm its authenticity by checking it against the UDI database etc.
Challenges in Blockchain Adoption

Transferring the EUDAMED database completely on the blockchain is possible. However, it can be met by several challenges such as

Failure to Cope with Decentralized Nature of Blockchain

Since blockchain is a completely decentralized network, it can be difficult to shift EUDAMED entirely onto a blockchain system since MDR and IVDR are under the constant influence of one or more controlling bodies.

Failure to Comply with Confidentiality Requirements

MDR and IVDR require manufacturers to show compliance with their confidentiality requirements. Manufacturers who have a blockchain network can face difficulties in showing compliance to those requirements since every participant of the blockchain can witness all ongoing activities on the blockchain network.

How Businesses can Take Privacy Measures in Blockchain?

As mentioned above, confidentiality is an important issue in having a blockchain network. For additional privacy and security, businesses may procure additional privacy and security through private blockchain and additional encryption. But having a private blockchain instead of a public blockchain can stop businesses from availing many benefits such as:

  • A public blockchain has bespoke software infrastructure whereas a private blockchain requires building a new infrastructure to facilitate its operations.
  • Having a private blockchain can be time-consuming and costly since each participant requires to be individually approached and provided with access rights.
  • Having a private blockchain increases operational costs since it does not offer the same benefits.
EU Blockchain Observatory and Forum

On 1 February 2018, the EU Commission announced the launch of the EU Blockchain Observatory and Forum. It will monitor and analyze different issues and trends related to blockchain. The forum can also help in smooth transitioning of EUDAMED on a more reliable blockchain-based solution

Alysidia as a Reliable Blockchain Solution for EUDAMED & UDI

Alysidia is a reliable solution provider for all EUDAMED issues and UDI related requirements for medical devices, and other related products. Companies can contact Alysidia to know more details and finally leverage from the advantage of our reliable solution taking care of all the issues.


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