By Maurizio Suppo, Principal Consultant, Qarad
Good old days will be gone forever – the new EU MD and IVD regulations are coming fast!
The European regulatory framework for MDs and IVDs has been driven since 2000 by the respective Directives (93/42/EEC for MDs and 98/79/EC for IVDs), which presented manufacturers with a scenario of medium regulatory complexity. These Directives allowed fast and relatively easy EU access to the vast majority of IVDs and Class I MDs in the “self-certification” class with no pre-market involvement of any 3rd party.
Only about 15% of IVDs fall into the Annex II List A or B or self-test categories; most others will need pre-market approval of a Notified Body.
All of this is about to change for good.
The Regulation Timeline
In 2012, the EU Commission responded to public pressure triggered by some medical device-related scandals (i.e. French PIP breast implants, metal-on-metal prosthesis) by initiating revision of all European Directives dealing with medical devices and in-vitro diagnostic products.
The legislative path involved both the EU Parliament and the EU Council, and has resulted in the first official negotiated text (June 27, 2016) of the proposed future Regulations for both medical devices and IVDs.
The shift from Directives to Regulations already indicates the firm intention of the European Commission to move to a stronger, stricter regulatory scenario than the one currently offered by the Directives. A European Regulation is a law in itself from the moment it is published and, unlike the Directives, does not need to be transposed into the legislative frameworks of each European Member State in order to become a law.
The future MD and IVD regulations are now going through review by the EU legal services and translation offices, and will be published in early January 2017 with a 5 year transitional period (3 years for MDs) before it will become fully enforceable.
No major changes are expected between now and the official publication on the Official Journal of the European Union.
A publication in January 2017 means that the both Regulations will become fully applicable by January 2022, date in which the current IVD and MD Directives will cease to be applicable. Going forward, only products which comply with the IVD-R and MD-R will be allowed to be placed on the EU market.
These regulations represent a drastic ramp-up of the European regulatory requirements, which will shift very much in a “FDA-like” direction in terms of cost, time & complexity although with different technical modalities for product registration.
For this very reason, one of the key concerns in the industry is that the European market, usually the very first in which new IVDs are launched, may lose its competitive edge.
EU Regulatory compliance will become more complex, resource-demanding and costly.
Major Changes in the Regulation
- Classification revolution! Almost the totality of the IVD assays will require the pre-market assessment of a Notified Body in order to be cleared for the EU market. Very few will be exempted from the NB pre-market control: instruments, culture media, biological stains, specimen collection devices (if not sterile)
- IVD manufacturers will face major efforts in order to produce the level of clinical evidence required by the IVD-R for each one of their assays regardless of how long such products have been on the market.
New Categories of IVDs Specifically Identified
- NPTs: Near Patient Tests (also known as Point of Care) – special requirements for getting clearance by NBs
- CoDx: Companion Diagnostics – approval will be very complex, costly and will involve the European Medicine Agency
Additional Updates
- Fewer Notified Bodies that are more powerful, more demanding and costly.
- Scope expansion: now importers and distributors are officially covered with specific roles and responsibilities.
- Conformity Assessment Procedures will be more complex, lengthy and costly. Involvement of Notified Bodies, the Medical Devices Coordination Group, EU Reference Laboratories (for IVDs) and, for CoDx the involvement of the European Medicine Agency.
- Very significant expansion of manufacturer’s requirements on medical vigilance and post market surveillance. A 12 fold increase in size of text compared with the Directive!
- Requirement to designate a Person Responsible for Regulatory Compliance.
- Tougher requirements for Laboratory Developed Tests
- Increased liabilities for defective products for both manufacturers and EU Authorized Representatives
- The obligation to post all IFUs online regardless of how they are distributed (paper or electronic IFUs)
- Still not 100% clear rules on the reuse (refurbishment) of single-use MDs
Planning Ahead
The changes to the IVD and MD regulations in the EU will require many manufacturers to make drastic procedural updates. But before you rush to make changes, I advise that you seek out as much information as you can about the regulation and its ramifications for your business. Qarad and United Language Group work together to provide consulting and multilingual e-labeling services to our shared clients.
