“Biology and Technology are evolutionary processes in which the information processing tools of prior generations are used to make those of the next. As these tools improve, the time between advances in order and capability decreases exponentially” – Ray Kurzweil.
Each round of technological improvement begets another and these rounds replace their predecessors at a continually quickening rate. Medical Devices is no exception to this pattern. The industry has moved on frighteningly quickly in recent years morphing from a predominantly standalone hardware and equipment manufacturing industry into one that delivers digitally integrated tools and treatments, connecting physicians with patients and their pathologies like never before.
One unfortunate by-product of these rapid cycles of innovation is that governmental bodies are destined to produce retrospective legislation which does not reflect contemporary market safety, efficacy and usability issues. The new Medical Device Regulation, which will come in to full effect on May 26th, 2020 following a 3-year transition period which officially commenced on May 25th, 2017 is a response to this deficiency and an attempt by European Authorities to bring Medical Technology and legislation into equilibrium.
Regulatory Compliance Professional
A recent report by Lloyd’s Register found that device makers must be prepared for investment in significant increases in personnel and financial resource when the MDR kicks in. There has always been a disparity between supply and demand of talent in Medical Devices and the new MDR highlights this fact once again. Article 15 sets out the requirement for each organisation to have available a ‘Person responsible for regulatory compliance’.
These individuals must be able to demonstrate the following qualifications:
- A formally recognised qualification within a closely related discipline
- Minimum of four years professional experience in regulatory affairs/quality management relating to medical devices
These individuals will carry out the following duties:
- Ensuring conformity is adequately assessed before device batch release
- Keeping technical documentation and declarations of conformity up to date
- Ensuring that new post-market vigilance reporting obligations are met
There is some provision within the article to protect micro and small entities from the financial brunt of this provision, however. Businesses with fewer than 50 employees and a turnover not exceeding €10 million are not obligated to house this individual within the organisation. They are required only to have such an individual ‘permanently and continuously at their disposal’.
Greatly increased pre-market scrutiny for high-risk devices
With increasingly complex technological advances have come new, previously non-existent threats to patient safety, whether that be through accidental malfunction or malicious ‘hacking’.
The obvious dangers have led to the gradual building of more robust device scrutinising processes before they reach the market. Since 2013 for example, notified bodies (independent 3rd party organisations responsible for giving new devices the go-ahead through a ‘conformity assessment’) have had their independent authority trimmed by the introduction of joint assessments carried out by other member states and the European Commission itself. Such has been the success of the initiative, it will now be codified within the new regulation.
For Class III and Class IIb devices (drug delivery) notified bodies will now be required to consult with a panel of experts who will present their view of the notified body assessment of the clinical file.The notified body may reject the panel’s findings, this must be justified and held as a digital record within EUDAMED.
Classification changes
Whilst the new regulation has not fundamentally altered any of the device classification divisions (still 4 basic divisions, 90% of devices expected to remain in the same class), the boundaries themselves have been redrawn to decrease the number of Class I devices, shrinking the overall percentage of devices placed on the market without conformity assessment through a notified body.
Here’s a list of the key modifications on their way:
- Any substance-based devices intended to be introduced into the human body via an orifice or skin application cannot be Class I (Rule 21)
- Many software-based medical products or apps are set to be reclassified, moving from predominantly Class I to Class II (Rule 11)
- Active therapeutic devices, including closed loop systems or automated external defibrillators, will also now be re-classified as class III. (Rule 22)
- All devices incorporating nanomaterials will be classified as Class IIa and above, variable dependent upon the likelihood of internal exposure (Rule 19)
Some opportunities
At first glance, the new 175-page regulation appears to overwhelm manufacturers, notified bodies, member states and the European Commission itself with a mountain of bureaucratic legwork. Certainly, the 3-year transition period is causing upheaval as all parties’ scramble to ensure that they are doing their part to minimise disruption in the flow of devices to market.
But when the dust settles the long-term outlook for commerce is positive for the European Medical Device market. Here are a few reasons why.
Effective federalisation of the CE mark
Under the new MDR, CE marking will move closer in spirit to the federalised FDA accreditation whereby approval in the EU will give device makers access to all member state markets. The previous system of member state specific notified body conformity assessments has led to uneven, convoluted approval processes for device makers. In the long term the effective federalisation of the CE mark will enable the EU market to compete with the dominant US market, developing greater levels of confidence, particularly amongst US device makers in the viability of OUS expansion.
Another step towards global harmonisation of accreditation processes
The accepted wisdom is that achieving CE mark is comparatively simple versus the more elaborate and unforgiving FDA approval process. One of the overarching themes of the new regulation is knowledge sharing, accountability and the need for further professionalisation of the CE marking process. These elements are going to create a more exhaustive regulation system, mirroring many of the best practices already necessary for gaining access to the US market. Continued steps in this direction can only serve to level the playing field and break down international trading barriers for SMEs who are hopelessly outspent on market access and regulatory accreditation by their blue-chip competitors.
Concluding Thoughts
The new MDR will require more than the acquisition of new skills. it will require a shift in mindset as the EU market overhauls an outdated system and brings legislation into line with the experience of end users and patients. Businesses will require strong, able leaders not merely to cope with regulatory changes but to prepare themselves to capitalise on long-term opportunities which the new regulation will bring.