MDR And IVDR Fail Risk-Benefit Assessment, EU Reg Expert Says
Executive Summary
"I fail to see any merit in this piece of dismally bad legislation. It is absolutely in no one’s interest," says consultant and regulatory expert Jaap Laufer, who predicts disastrous impact on many companies and the end of notified bodies as we know them.
The EU failed to do its homework properly and the result is two new Regulations, the Medical Devices and IVD Regulations (MDR and IVDR), that are going to cripple notified bodies and manufacturers. That is the personal view of consultant veteran medtech regulatory expert Dr. Jaap Laufer.
EU institutions are going to have difficulty defending the impact of these texts as patients see products disappear and prices rise, Laufer said in an interview with Medtech Insight.
Laufer stressed that these opinions are his own and do not necessarily reflect the opinion of consultancy Emergo, where he works as medical director. But they make for thought-provoking reading and are a reminder, as we approach the end of 2017, an eventful, but equally frustrating, year for EU medtech, of the broad context in which medtech stakeholders are currently struggling.
"The impact may be compared to a man falling from the 12th floor to his death, while shouting at every floor that he is still doing fine."
The onerous incremental requirements for manufacturers, the ill-defined support structures, such as the nebulous MDCG [Medical Device Coordination Group], the accelerating demise of notified bodies with devastating impact on both established, well-functioning manufacturers and startups, and the stifling of innovation are amongst the deeply disturbing effects this poorly written and ill-considered regulation is starting already to have on the supply of medical devices. It is not inconceivable that a very substantial number of European manufacturers will disappear within 5-7 years.
The main reason why all of this is happening lies in the fact that the original "Impact Assessment" by the EU Commission was performed in 2012, well before the deeply impacting 800 Roth-Behrendt amendments. The European Parliament and the Council of Minsters never demanded a re-evaluation of the new draft regulation, and approved it without any understanding what the changes meant.
As a leading notified body speaker recently mentioned, the impact may be compared to a man falling from the 12th floor to his death, while shouting at every floor that he is still doing fine.
Legacy products, those that have been on the market for decades without problems, will be the first to disappear as manufacturers cannot invest substantial amounts for these mostly very moderately priced devices. I can see essential surgeries and other interventions being cancelled because of this problem that the Council could resolve by simply issuing an emergency Regulation overriding the Medical Devices Regulation, for this explicit purpose. In addition, competent authorities should step in where notified bodies are overwhelmed to prevent irreparable damage to the device flow for patients.
Longer term we will see a lot of manufacturers going out of business, as well as additional notified bodies- the business will become unviable. It is hard to predict how many, but some experts say it may be up to 30% of manufacturers. Large manufacturers will survive, but hesitate to bring medium-risk products to Europe, when the hurdles have grown so unacceptably high.
This is in sharp contrast to the US, where the introduction by the FDA of the aspect of “medical need” (unmet or otherwise) is starting to affect a facilitation of new products, just as the pressures increase in Europe. Many well-established companies in Europe will disappear without a chance of ever coming back with their knowledge lost forever.
"Competent authorities should step in where notified bodies are overwhelmed to prevent irreparable damage to the device flow for patients."
Last, but not least, November 27 saw a gunshot application run by less than 30mostly Team NB members to get re-accredited and re-notified under the new MDR and IVDR. The applications will have to be processed, and then a schedule will have to be published for audits by the multinational Joint Audit Teams, the international accreditation groups who do the work on the ground. Not only are there preciously few auditors who can do this elevated scrutiny, but the track record of the JAT has been up to about 7 applications per year. This would mean many notified bodies would be accredited too late to achieve accreditation by the time the MDR and IVDR fully apply, and consequently a disastrous number of manufacturers will be “orphaned”, as they won't be able to be recertified within the transitional time.
I do not see any improvement under the current system any time in the foreseeable future, but rather a general demise of the system as we know it as more notified bodies depart or shrink their scopes. In my opinion, the notified body system for medical devices is bound to disappear under a successor piece of legislation that will establish an “EMDA”, a European Medical Devices Agency that will absorb the major notified bodies, as we know them, into national agencies that are subsidiaries to the EMDA.
"In my opinion, the notified body system for medical devices is bound to disappear under a successor piece of legislation that will establish an 'EMDA,' a European Medical Devices Agency."
In short, I fail to see any merit in this piece of dismally bad legislation. It is absolutely in no one’s interest.
"Some products, notably legacy products, will be killed by their manufacturers fairly soon; others will disappear suddenly."
In parallel, the quality of notified bodies as well as the level playing field for them should be drastically enforced, especially with regard to the need for clinical evidence. The latter is still not the case and, in my opinion, will not be either under the MDR nor IVDR. This may be because the notified bodies are run by engineers, even though they increasingly employ a medical doctor and because the MDCG will not have the expertise to review dossiers in a scientific and timely fashion.
With regards to our clients, we would advise to critically assess whether the current clinical evidence for their products in the wider sense is adequate or needs improvement, and whether post-market systems are functional, or need to be increased in effectiveness. In the short term, we may offer our support which, by necessity, has to be tailored to their specific needs. One word of caution: It is better to be alert early on than wait until it may be very difficult, if not impossible, to remedy a situation.
"The best thing that could happen is a rescission of the regulation in its present form and a redraft."
From the editors of Clinica