Management of REACH regulation compliance in manufacturing of dental imaging devices
Inget, Sara (2023)
2023
Bioteknologian ja biolääketieteen tekniikan maisteriohjelma - Master's Programme in Biotechnology and Biomedical Engineering
Lääketieteen ja terveysteknologian tiedekunta - Faculty of Medicine and Health Technology
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Hyväksymispäivämäärä
2023-07-11
Julkaisun pysyvä osoite on
https://urn.fi/URN:NBN:fi:tuni-202306307018
https://urn.fi/URN:NBN:fi:tuni-202306307018
Tiivistelmä
Chemical substance regulations are changing fast in the European Union (EU), and this sets challenges to many companies, including medical device manufacturers, to stay compliant. The regulation on Registration, Evaluation, Authorisation, and Restriction of chemicals (REACH) EC 1907/2006 is the main chemical legislation in the EU and it puts the responsibility of managing the risks arising from the chemicals to the industries. If a chemical is identified as Substance of Very High Concern (SVHC) it is added to the REACH Candidate List and manufacturers, suppliers and importers of articles that contain SVHC over 0,1 % (w/w) are obligated to inform the recipients of the articles of the presence of SVHC. If more than 1 ton per year of each SVHC substance is put to the EU market, the manufacturer or importer is obligated to notify the European Chemical Agency (ECHA).
A case company for this study is Finnish manufacturer of dental imaging devices, and it needs to comply with the REACH regulation, especially with those parts concerning of articles and complex objects. The number of SVHC in the Candidate list is already 233 and new substances are added to the list approximately every six months. This sets a challenge for the manufacturer to manage the REACH compliance for the devices, which consist of thousands of components. Besides the REACH, also other legislations are setting restrictions on the use of certain substances in the dental imaging devices, and they are partly overlapping with the REACH regulation. This overlapping can be utilised when developing and improving processes for managing chemical legislation compliance. The REACH regulation does not require testing of the SVHC in the articles and assessing the absence or presence of SVHC over the limit as using the information available from the suppliers is considered to fulfil the legal obligation. Therefore, the suppliers are in a key role when setting up a process for managing REACH compliance.
Process for managing the REACH regulation compliance for the case company was developed by performing a gap analysis and using risk assessment. Case company’s current processes for other chemical legislation compliance were reviewed, as well as its sister company’s processes. Also, previous practises and workshops for assessing the REACH compliance were reviewed during the study to comprise a new process using the most useful and practical methods learned from the existing processes. Risk assessment tool was established to categorise suppliers based on the components or materials they are supplying. The required documentation for assessing the compliance was based on the risk of the component or material containing SVHC over 0,1 % (w/w). High risk components and materials require supplier declaration and medium risk requires review of material safety data sheet or other similar documentation where material composition can be reviewed. Low risk components do not need separate documentation or review as the quality agreements with the suppliers are updated to include REACH compliance requirement.
As a conclusion, the developed process complements the REACH compliance requirement that is added to the supplier quality agreements, and therefore risk-based approach is a suitable option for managing the compliance with constantly changing regulation. The risk assessment criteria are also easily modified if there comes a need to have stricter control over the compliance.
A case company for this study is Finnish manufacturer of dental imaging devices, and it needs to comply with the REACH regulation, especially with those parts concerning of articles and complex objects. The number of SVHC in the Candidate list is already 233 and new substances are added to the list approximately every six months. This sets a challenge for the manufacturer to manage the REACH compliance for the devices, which consist of thousands of components. Besides the REACH, also other legislations are setting restrictions on the use of certain substances in the dental imaging devices, and they are partly overlapping with the REACH regulation. This overlapping can be utilised when developing and improving processes for managing chemical legislation compliance. The REACH regulation does not require testing of the SVHC in the articles and assessing the absence or presence of SVHC over the limit as using the information available from the suppliers is considered to fulfil the legal obligation. Therefore, the suppliers are in a key role when setting up a process for managing REACH compliance.
Process for managing the REACH regulation compliance for the case company was developed by performing a gap analysis and using risk assessment. Case company’s current processes for other chemical legislation compliance were reviewed, as well as its sister company’s processes. Also, previous practises and workshops for assessing the REACH compliance were reviewed during the study to comprise a new process using the most useful and practical methods learned from the existing processes. Risk assessment tool was established to categorise suppliers based on the components or materials they are supplying. The required documentation for assessing the compliance was based on the risk of the component or material containing SVHC over 0,1 % (w/w). High risk components and materials require supplier declaration and medium risk requires review of material safety data sheet or other similar documentation where material composition can be reviewed. Low risk components do not need separate documentation or review as the quality agreements with the suppliers are updated to include REACH compliance requirement.
As a conclusion, the developed process complements the REACH compliance requirement that is added to the supplier quality agreements, and therefore risk-based approach is a suitable option for managing the compliance with constantly changing regulation. The risk assessment criteria are also easily modified if there comes a need to have stricter control over the compliance.