A medical device is any product or equipment intended to be used for a medical purpose.
Key contributions of nonwovens, both visible or unnoticed, can be found in a number of medical devices (including in vitro diagnostics) such as :
- components of rapid diagnostic tests
- face masks
- products for wound care and continence management
Medical devices are essential for our lives insofar as they bring vital benefits to patients and healthcare professionals, in their various functions to diagnose, prevent, monitor, predict, treat or alleviate diseases.
The new regulatory framework for medical devices in European Union is governed by two main references:
- Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on Medical Devices, Amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and Repealing Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices.
- Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on In Vitro Diagnostic Medical Devices and Repealing Directive 98/79/EC and Commission Decision 2010/227/EU
The Regulations ‘entered into force’ on 25 May 2017 with three and respectively 5-year transition period.
What are the conformity modalities?
In the EU, a system that focuses on the level of potential hazard inherent in the type of device concerned is the key to prove the medical devices are safe and effective. The classification of medical devices is outlined in Article 51 of the Medical Devices Regulation (EU) 2017/745 and Article 47 of the In Vitro Diagnostics Medical Devices (EU) 2017/746, ranging from low risk to high risk.
Medical devices have to undergo a conformity assessment to demonstrate that they meet legal requirements to ensure they are safe and perform as intended. The conformity assessment depends on the risk class. Class I medical devices (excepting those that are re-useable, require sterilization or have a measurable function) can be marketed based on self-certification. Moderate to high risk class devices necessitate an audit of the manufacturer’s quality system by a Notified Body and, depending on the type of device, a review of technical documentation of the manufacturer on the safety and performance of the device.
Manufacturers can place a CE (Conformité Européenne) mark on a medical device once it has passed a conformity assessment.
Ensuring compliance of medical devices with relevant legal requirements
Article 10 of the MDR and the IVDR comes with a set of obligations for manufactures, such as:
- Confirm that the product is a medical device according to the Annex VIII of the MDR and IVDR)
- Ensure general safety and performance requirements are met, including for labelling and technical documentation and quality management systems (Annex I of the MDR and IVDR)
- Meet the requirements for clinical evidence (Annex XIV of the MDR and IVDR)
- Appoint a person responsible for regulatory compliance in place (Article 15 of the MDR and IVDR)
- Ensure economic operators in the supply chain are compliant and sufficient financial coverage is in place, in respect of a manufacturer’s potential liability (Article 10 of the MDR and IVDR)
- Ensure the new vigilance reporting timescales are met and that an annual periodic safety update report is created (Chapter VII, Section 1 and 2 of the MDR and IVDR)
Medical devices and nonwovens
Nonwovens are present in almost all the daily use applications, some of them being essential healthcare products. An extensive list of medical applications is available here.
The new regulatory framework on medical devices and in vitro diagnostic medical devices significantly impacts the entire supply chain. Manufacturers must ensure that products conform to the regulations at every stage. There are additional and more stringent requirements for risk management and hazardous substances, supply chain obligations, clinical evidence, labelling. post market clinical follow up and safety reporting, traceability (Unique Device Identification (UDI) system) and transparency (Eudamed database). Changes in the regulatory obligations of operators across each product supply chain include establishing and maintaining quality system requirements for all those involved in the design, manufacture, inspection or testing of the product or any components used therein.
EDANA closely follows up and advises its members on the impact of the new Regulations and work to support companies across the entire supply chain in complying with the complex regulatory framework.
EDANA highlights the value and contribution of the nonwovens and related industries that play a major role in producing materials essential for patients, healthcare professionals and society.