How Will The Upcoming CE Changes Affect the European Union?
The 'CE' mark for biotechnology and medical devices has long been an attractive goal for companies large and small to enter the European market. Often regarded as the 'easier path' versus the FDA, the CE mark – and subsequent European sales – have been a starting point for many start-ups.
However in 2017, the EU expects to see significant changes to the regulations regarding CE, including more stringent standards for approval as well as a change in continuing standards for existing devices. Changes include replacing the current Medical Device Directive (MDD) and the directive on Active Implantable Medical Devices (AIMD) with the new "Medical Device Regulation" (MDR). It also implements changes to the current directive for In Vitro Diagnostics (IVD) and alters the scope for what is considered a 'medical device' or 'active implantable'.
The MDR, as proposed by the European Commission back in 2016, stated it would include, "…groups of products without an intended medical purpose that are listed in Annex XV [and] accessories to medical devices and products…”. This means many therapies and products not previously defined as medical devices, such as contact lenses, dental materials, electromagnetism therapies (like rTMS ) and even cleaning products will now be included in the MDR. There will also be the new 'Common Specifications' in addition to the existing 'Harmonized Standards' and 'State of the Art'.
The most significant impact of the new standards, expected to be approved in 2017 and mandated by 2020, is a more controlled CE certification process with a more centralized governing body. Currently the CE mark approval process enjoyed oversight by simple agreement-of-standards amongst member states, with the individual states holding the reigns on the CE mark compliance and certification process. A goal for the new statutes is to remove the discrepancies between Competent Authorities (CA) and Notified Bodies (NB) that exists under this arrangement.
Some of these changes include the organization of 'expert panels' which may, upon their option, offer an opinion to the technical sufficiency, efficacy, and quality control information submitted by device developers and manufacturers. It also includes the formation of a common database (EUDAMED) which contains submissions about serious incidents regarding medical therapies - AKA Field Safety Corrective Actions (FSCA). These vigilance reports will be made available to the public, as well as all member states.
As a part of the 'greater accountability' mindset of the new standards, manufacturers and marketers will be required to provide a significantly more competent, and liable, Authorized Representative (AR) to oversee the compliance process. This will include increased legal and civil penalties in the event of device failure, and a requirement for NBs to maintain liability insurance in the event a certificate is withdrawn.
Many NBs have already indicated they cannot process these extra demands, leading to the possibility of already-approved devices leaving the European market. The more demanding liability will also functionally lead to NB's need for more competent staff, with greater restriction, and more fiscal and legal obligation. As a result overhead will significantly increase, putting pressure on smaller companies and start-ups, and making it harder for entry into the market.
The loss of approved devices within the EU could also be exacerbated by similar restrictions in accountability for non-EU NBs and manufacturers. As an example, importers and foreign companies will have to endure increased liability for defective devices, and non-European manufacturers will have higher costs and more hurdles to entering the EU marketplace. This puts pressure on incentives for manufacturers to share information with certifying bodies. And while the obligations for the local distributors are specified, it's left unclear who would be liable for a compliance failure.
In addition, more rigorous product testing and clinical trials will be expected in order to receive certification. The entire CE process is migrating from a 'new design' format to one of a 'product lifecycle', similar to what the FDA and other international standardizing agencies employ. The European Guidance (MEDDEVs) focuses on Guidance for Authorized Representation, Clinical Evaluation, Vigilance, and PostMarket Clinical Follow-Up – meaning NBs would be placed under more strict supervision.
Equivalence, which is frequently used to apply for CE-marks on lower-risk therapies, will be reduced in stature and NBs must provide more evidence of efficacy. Even in cases where equivalence is allowed, it will be more heavily scrutinized and will not, in and of itself, be a sole pathway to approval.
The bottom line is; gaining entrance to the European market will be a far more challenging process than it has been historically. While the guidelines are clear in their fundamental goals (greater efficacy and accountability towards producers), exactly how these will be enforced is left in a grey area. Fees and penalties are strongly implemented, however who will be the ultimate 'payer' for violations is unclear and I suspect will be 'shaken out' through a system of legal trial and error. This insecurity makes planning difficult for new companies, and – in and of itself – may become a deterrent.
The European market has been attractive due to its more relaxed certification process for device importers and manufacturers, and its more 'self-regulated' nature of operations. However the salad days for medical device markets in the EU may be entering the doldrums. While this is likely a vast improvement for patient safety, it may result in a slow-down of new development and negative impacts to the profitability and variety of medical technology upstarts, especially in the range of small to medium companies.
Further reading:
https://www.emergogroup.com/services/europe/ce-certification
https://www.mdtmag.com/blog/2016/09/new-regulations-ce-changing-landscape-medical-devices-europe
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