Medical Devices Regulations and nonwovens 

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.

Activities and documents during the 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.

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.