Upcoming changes to CE-Mark Regulations for Class III Medical Devices

European Regulations for Class III Devices – Gazing into the crystal ball


Most medical devices professionals in the United States are aware of the European Union’s (EU) regulatory framework that is generally referred to by the phrase “CE-Marking”. It is a process that was first implemented in the 1990s, and designed to ensure that any devices placed on the market were well designed, safe for the user and operator, and were manufactured and distributed under a formal quality system. On the whole it has worked well, has allowed innovative devices to reach patients in a reasonable time span, and has proven to be much less onerous for the company compared with, say, FDA PMA approval.

But, like any process that is twenty years old, it is probably time for an update. Fundamentally it is a good process but there are gaps in the rules, which have allowed patients to be exposed to faulty or dangerous products.

There is also increasing demand amongst consumers and payers to know more about the effectiveness of new devices, not just about whether they are safe or not. In the case of many Class III devices, their high-tech nature can obscure reasonable debate on efficacy and therefore hamper reimbursement decisions based on cost-effectiveness.

Finally, whilst the principles on which the European regulatory framework was developed remain good, the reality has not quite caught up. In particular, the ability of the authorities in each Member State to share information on device registration (e.g. the clinical dossier data used in CE-Mark applications), or follow up (e.g. Vigilance reports – EU post-market surveillance) with each other is poor. Individual states are meant to supervise the Notified Bodies (testing houses) so that all CE-Marks should be the same level of confidence, but this is not happening.

So, what to do about this?

It’s a no-brainer that one global perfect regulatory test to identify good vs. bad devices is the ultimate. One set of rules, one study, one application, one approval. Much less cost in time and money for the manufacturer, which should lead to less costs for healthcare payers, bigger margins for industry, and safer devices for the end users – everybody wins.

But how to reconcile the EU framework with those in the United States, Asia, Australia? For years all areas have thought they had the best approach, but each could point to deficiencies in the other systems – “We get devices to market five years ahead of those guys”; “We have far fewer dangerous devices reaching the market because we take our time”; “Our healthcare system doesn’t pay for devices that are not proven efficacy”; or “Our system allows Doctors to decide what works in their patients, not a bean counter in the capital city”. Hence the Global Harmonization Task Force for Medical Devices. The current moves to change the EU regulations in part derive from these efforts and changes will help in the move towards global harmonization. Don’t hold your breath – it won’t be here just yet though.

So, there is now an EU initiative to improve the current process.

Objectives of the EU initiative

To quote from the EU Commission documents, the forthcoming revision pursues three overall objectives:

A: To ensure a high level of protection of human health and safety

B: To ensure the smooth functioning of the internal market

C: To provide a regulatory framework which is supportive for innovation and the competitiveness of the European medical device industry

In addition, several specific objectives related to the individual problems identified contribute to the achievement of the overall objectives:

1: Uniform control of Notified Bodies

2: Enhanced legal clarity and coordination in the field of post-market safety

3: Cross-sector solution of “borderline” cases

4: Enhanced transparency regarding medical devices on the EU market, including their traceability

5: Enhanced involvement of external scientific and clinical expertise

6: Clear obligations and responsibilities of economic operators, including in the fields of diagnostic services and internet sales

7: Governance – efficient and effective management of the regulatory system

Who will be the winners and who will be the losers with these changes?

Almost everyone should benefit, as the playing field gets leveled  and more information is shared and made available. Hopefully the only losers will be unscrupulous manufacturers and distributors. A recent example is PIP – the French manufacturers of silicone implants who used industrial rather than medical grade raw material, so putting many patients at risk.

    • Patients and end-users should benefit through continued fast approvals, albeit with more thorough independent, better supervised and consistent testing. They should benefit from more thorough follow-up of devices after they are on the market with improved traceability and abilities to manage recalls.
    • Healthcare professionals should benefit with better information on the benefits of new devices;
    • Manufacturers should benefit as the changes head off any country-specific regulation, dishonest competitors are found out and excluded from the market, and specific changes are made to encourage and facilitate innovation from small and medium sized companies. Improving the EU regulatory framework maintains the single market across all 33 countries (EU, EFTA and Turkey).

What can a manufacturer from outside the EU, planning to launch sometime in the future, expect to encounter?

Today’s manufacturers can expect to encounter a somewhat confused situation for the next year or two. The more diligent and well-run Notified Bodies and/or their Competent Authorities have been introducing some aspects of the forthcoming changes for some time now. These have not been imposed by legislation, more by those organisations themselves applying current rules in a particular fashion. An example may be where an active implantable medical device manufacturer applies to be allowed to affix the CE Mark to his new product, and the Notified Body gives an approval conditional upon the manufacturer conducting a post-market surveillance study on CE-marked devices for a certain period of time or number of implants. The Notified Body will then audit the study and can disallow CE-Marking if they are not happy with the outcomes. But this can’t be a fair approach – a less diligent manufacturer with a similar device could choose a less diligent Notified Body, have his product on the market sooner, but without the same safeguards for the patient. As the supervision of Notified Bodies improves, manufacturers should see such differences disappear.

The Notified Bodies will be given stronger powers to ensure that adequate testing, manufacturing, marketing, and follow-up is being undertaken. This will include the possibility for surprise factory visits – inspections that avoid the “just do it how the QA Manager says, only for the audit week” phenomenon.

Manufacturers (and their supply chain) will have to ensure an effective traceability for their products. Not only manufacturers will be affected – this will also impact the purchasers (e.g. hospitals or distributors) if they come between the manufacturer and the end-user / patient.

Probably the most important change that will affect anyone planning a product launch in the near future concerns clinical evidence. The requirement for clinical evidence in the CE-Mark application has always been relatively low, especially when compared to the demands of the FDA pre-market approval process. In devices of lower risk than Class III it would usually be absent altogether, and different Notified Bodies would interpret the need for clinical evidence in different ways for Class III products. The clinical data would only need to provide justification for claims of safety – there was no need to prove efficacy. We can take for example an implanted blood pump. The manufacturer may only need to prove that it pumps blood without significant hemolysis, without electrocuting the patient or the people around him or her, and that the device is built under an approved quality system. Okay – it’s not as simple as that but in the interests of brevity it’s not far off. In the future, if the manufacturer says that it pumps blood, restores circulation, and will do so for the next five years, then they will have to follow a cohort of patients long enough to back-up these claims. It will also give the Notified Bodies a way to assess if the data used to compile the clinical data part of the CE-Mark application was indeed relevant to the group of patients in whom the device is subsequently used.

This will have knock-on effects for manufacturers. It will become rather risky for a manufacturer, on gaining the approval to apply the CE-Mark, to simply put his device on the market and let the market do with the device what it wants. It will be in the manufacturers interests to try and optimise the outcomes for the product, collect performance data that supports ongoing CE-Marking, and generates positive data useful when undertaking cost vs benefit decision making at the purchasers. That will – undeniably for complex devices – suggest that investment in excellent training, education and support as well as in study design and management will pay off. Smart companies have always known this – the difference in the future is that failure to appreciate this may result in loss of the CE-Mark and therefore exclusion from the markets of the EU.

Manufacturers will need to coordinate their employees, distributors, agents, shippers – all the supply chain – better than before. Insofar as Vigilance reporting is concerned, there was inconsistent coordination across the whole range of different Competent Authorities. Consequently, a Distributor in Denmark may have felt little connection with the activities of a Sales Specialist in Sweden or an Agent in Ankara. With better communication amongst the authorities a Vigilance report ignored but identified in any one of these places may rapidly affect the business across the whole of the EU.

When do we need to make these changes?

As always with the way that the EU works, this is not an easy question to answer. The EU Commission needs to come up with final proposals, and these need to be adopted (into the legislation of each Member State). The current target for adoption is 2014. There will then be a transitional period which could last up to five years – so 2019. Different countries will adopt at different speeds, and will differ in their own transition periods.

So you think that 2019 is a long way off so you don’t need to worry? Possibly, but you might live to rue that decision. Why? Here are some examples of why you should incorporate these changes into your thinking today:

  • Business modelling – you may need to plan to keep those study monitors or that CRO on board for longer, or bring forward the date when you need to start building a field support organisation;
  • Investor expectations – no longer should investors think that a CE-Mark is a guarantee to marketability and that studies no longer need to be funded post-approval;
  • Distributor Contracts – if you are going to be signing contracts with Distributors, perhaps they are for five years duration, you will need to address who is responsible for collecting follow-up data, ensuring Vigilance is properly complied with, that traceability is managed correctly;
  • Study design – do you want to design your pre-CE-Mark or Feasibility Study with a follow-up Post-CE study or registry in mind, rather than waiting for it to be imposed on you by your Notified Body?
  • Notified Body choice – it is good to develop a long-term relationship with a Notified Body, so choose wisely now and you can avoid upheaval in the future should proposed changes cause your Notified Body to radically alter how they work;
  • Your own Quality Systems – it takes time to alter the quality culture in many organisations. It won’t be possible to do so just for the time it takes to survive an audit. So start now, get quality truly at the center of what you do, and you won’t worry that TŰV will be making an unannounced visit to your facility;
  • It might be 2019 in some countries, but what if Germany implements the changes in 2015?

So, the EU is going to be just like the USA?

Not yet. Even with the changes that are proposed the CE-Marking process will remain relatively simple, not too long, and aimed at allowing access to safe products that can be freely and fairly traded throughout the EU.

What about reimbursement?

Of course we could create a whole new info document on reimbursement, and one for each country at that. But it is probably reasonable to say that there will be a coming together of the expectations of the Notified Bodies with respect to device safety data and clinical data to support efficacy claims, and health outcomes data requested by payers. This may suggest to forward-thinking manufacturers that when planning their studies they incorporate health economics measures – for example quality of life, readmission rates, etc. – with careful planning to avoid learning curve or early-version data, but rapidly building  case data that would appeal to bodies such as NICE in the UK.

 If you would like more information, please contact us directly. Thanks. 

©Copyright First Clinical & Technical Services Ltd. 2012
Terry McCarthy, FirstClinTech, December 2012. Please note that any information herein contained is the opinion of the author only. First Clinical & Technical Services are not responsible for any errors or omissions nor for any loss or harm that may result from the use of this information by non-revenue Clients. By using this web site you are agreeing to this condition. Finally, if you would like to use this page, please acknowledge its authorship.