...and are classified according to risk from Class I to high risk Class III devices.
If a ‘Notified Body’ establishes that a device is in compliance with the ‘essential requirements’ then a CE-marking may be attached allowing the product to be sold throughout the EU.
It was a catastrophic product failure in the Poly Implant Prothese (PIP) breast implant which was the principal driver behind the reform of the current legislation – the Medical Devices Directive (93/42/EC) and Active Implantable Medical Devices Directive (90/385/EC) and the In-vitro Diagnostic Medical Devices Directive (98/79/EC).
The new European Medical Devices Regulation (MDR) and the In-vitro Diagnostic Medical Devices Regulation (IVDR) became law on 25 May 2017 initiating the transition period (3-years for the MDR and 5 years for the IVDR). They will therefore come fully into force on 25 May 2020 and 25 May 2022 respectively.
A Regulation, unlike a Directive, is directly enforceable in each Member State so national implementation is not necessary thus avoiding national discrepancies in interpretation.
The two Regulations will mean greater scrutiny of technical documentation including stricter requirements on clinical evaluation and in-market follow-up through the supply chain including unique identifiers. In particular the Regulations establish a degree of EU-level control of high risk devices, extend to certain previously unregulated aesthetic products, improve the provision of information to patients including establishing a new European database of medical devices and device investigations as well as requiring manufacturers to collect data about device performance and EU countries to coordinate more closely in relation to market surveillance. In addition they impose more stringent rules on Notified Bodies including establishing the right and duty of these bodies to conduct unannounced.
The position of the Notified Bodies was examined recently when a recent European Court of Justice (ECJ) case on the role of Notified Bodies in the PIP case. The German notified body TÜV Rheinland was responsible for granting the CE-marking for the PIP products. In its judgment, the ECJ clarified Notified Bodies' obligations, saying that they must "take all the steps necessary" to ensure that they meet their obligations to ensure the device is in conformity. A French appeals court also ordered TÜV Rheinland to pay 60 million euros ($65.50 million) immediately to 20,000 victims of faulty breast implants.
The transition periods offers manufacturers the opportunity to update their technical documentation and processes to meet the new requirements. This is therefore a crucial time.