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 :
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 Regulations ‘entered into force’ on 25 May 2017 with three and respectively 5-year transition period.
Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 amends the Regulation (EU) 2017/745 on medical devices as regards the dates of application of certain of its provisions. This mean that 26 May 2021, the Medical Device Regulation (hereinafter MDR) will become fully applicable, following the transition period while the corresponding date of application of the In Vitro Diagnostic Medical Devices Regulation (hereinafter IVDR) remains in May 2022.
A plethora of guidance documents and implementing acts to ensure the Regulations are implemented properly have been published or will be released in the next future.
During the transition period, devices can be placed on the market under the current EU Directives (93/42/EEC, 98/79/EC and 90/385/EEC), or the new Regulations if they fully comply with these.
There is a so called ‘grace period’ beyond May 2020 where products can remain certified under the certificates issued according to the existing Directives for up to 4 years (MDR) and 2 years (IVDR) after the date it was issued. It is important to highlight that several MDR/ IVDR provisions such as the Eudamed database, post-market surveillance and new supply chain obligations will become applicable at the date of full application and the original certifying notified body must also be designated under the new Regulations to qualify. Self-certified Class I products are required to achieve full compliance on the date of application. Medical devices and in vitro diagnostic that will be up classified under MDR and respectively IVDR will need to be recertified by the date of application and this will require involvement of a Notified Body in the conformity assessment procedure. Failure to meet this requirement will result in product withdrawal from the market.
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.
Manufacturers can place a CE (Conformité Européenne) mark on a medical device once it has passed a conformity assessment.
Article 10 of the MDR and the IVDR comes with a set of obligations for manufactures, such as:
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.