The European Union’s regulation of medical devices in Europe only began in the 1990s. Previously, member states acted independently, but the differing national requirements were replaced by EU directives including the 1993 Medical Devices Directive (MDD) and the 1998 In Vitro Diagnostics Directive (IVDD).
Under the MDD, medical devices (MDs) are graded according to risk with the level of data and controls dependent on the categorisation. For class I (low risk) MDs the manufacturer may self-certify. For higher risk, class II and III MDs, certification is granted by notified or conformity assessment bodies.
The adequacy of the directives was called into question with the fraudulent use of non-medical grade silicone in breast implants manufactured by 'Poly Implant Prothese' (PIP). The PIP scandal in 2010 impacted nearly 400,000 patients in 55 different countries.
This PIP scandal, as well as safety requirements resulting from the substantial technological and scientific progress since the first regulations were introduced, led to the introduction in 2017 of two new EU regulations:
• The EU 2017/745 (the ‘MDR’); and
• EU 2017/746 (the ‘IVDR’)
The MDR finally came into force on 26 May, 2021 after a 12 month delay due to Covid-19 with the IVDR due to come into force on 26 May, 2022.
The EU hopes the rules will help to “consolidate” the EU’s role as a global leader in medical devices, allowing patients to benefit from innovative, high performing devices and new therapeutics in a more patient friendly environment where transparency and patient choice are a priority.
In summary, the MDR and IVDR introduce:
• Stricter pre-market control of high-risk devices;
• A new risk classification system for IVDs;
• Improved transparency through the EU database of MDs and IVDs (EUDAMED) involving unique device identifiers and other data;
• Device traceability through the supply chain ‘economic operators’ extending legal responsibilities from manufacturers to importers, distributors and authorised representatives;
• “Implant cards” for patients containing information about implanted devices together with a compensation mechanism to ensure patients are compensated for damage caused by defective devices;
• Stricter rules on clinical studies on MDs;
• An obligation on manufacturers to collect data about the real-life use of their MDs; and
• Improved coordination between EU Member States.
To avoid disruption of supply, devices covered by certificate issued in accordance with the MDD or IVDD (including class I MDs which are up-classified to class II or III) may continue to be supplied and marketed up to 26 May, 2025 provided there are “no significant changes” in the design and intended purpose of the legacy device.
The timing of the regulations was informed in part by delays in the development of the EUDAMED database, a web-based portal acting as a central repository for information exchange to help regulators conduct market surveillance. This was due to come into operation with the MDR but is now expected to come into effect with the IVDR. It is considered to be the heart of the new regime holding data such as unique device identifiers for devices and registration details for manufacturers and other economic operators.
With the MDR now in force, attention now turns to the details around implementation of the IVDR. Many of the same issues as apply with the IVDR as with the MDR and there are industry calls from deferment particularly around the perceived shortfall of notified body capacity.
From a UK perspective, currently the MDD and the IVDD, as implemented by the 2002 UK Medical Device Regulations, still apply. While the UK government’s intentions as to whether to align or diverge with the regulations are still uncertain, in the interim, a new additional section in the post-Brexit amendments incorporates into UK law some of the MDR changes.