After several years of discussion and public consultations, the European Commission has published its proposal for two regulations (which, after publication, will be immediately binding on all EU Member States without transposition into national law) intended to replace the existing directives: one on medical devices, MDs (the “MDR"), and the other on in vitro diagnostic medical devices, IVDs (the "IVDR").
Following a lengthy democratic legislative process, the EU reached a political agreement on these regulations on 25 May 2016 and they will enter into force 20 days after formal publication (expected by early 2017). Thereafter, there will be a transition period of three years for MDs and five years for IVDs before the regulations will become applicable.
Whilst there appears to be plenty of time for implementation, it is advisable for companies to be prepared and plan ahead meticulously in order to avoid problems later on when marketing such devices. Some of the changes that will be implemented by the regulations are summarised below. It is clear that manufacturers will have to review their existing products and procedures for conformity to the new rules and specifications.
Change to scope of definitions:
There will be new definitions of MDs and IVDs as well as enlarged scope of 'accessory' to MDs and IVDs.
Definitions of key concepts such as 'devices for near patient testing', 'self-testing', 'companion diagnostics' will change under the IVDR and, for example, 'single use devices' under the MDR will have an impact on the existing regulatory requirements.
Classification rules have been altered (and as such different conformity assessment procedures maybe required):
Certain riskier products will be reclassified as Class III;
Rules for software classification have been introduced;
Substance-based devices administered via a body orifice or applied on the skin are covered by a new special rule; and
IVDs are covered by new classification rules, and most will require some form of conformity assessment from a notified body. This represents a big departure from the current system where most IVDs fall under self-certification. Certain self-testing devices are reclassified from class C to B.
The rules on clinical evidence have been intensified:
Additional data may be required to enable manufacturers to be able to (continue to) market their products.
The generation of additional clinical evidence is needed to comply with the relevant notified bodies.
Clear and additional responsibilities of the respective economic players in the supply chain have been introduced:
All participants of the supply chain need to be aware of their respective role and responsibilities under the new rules, must verify their respective distribution, supply chain and other agreements accordingly and amend such agreements as necessary.
While manufacturers are explicitly obliged to have sufficient financial coverage for potential liability under the Product Liability Directive, the other parties to the supply chain are also advised to take additional insurance policies to cover their respective risks.
The MDR introduced an opt-in option on reprocessing for Member States, partially harmonising the rules on reprocessing but mainly increasing the questions for industry such as:
Will Member States permit reprocessing of safe use determinations and if so, how will they shape their national laws?
Can reprocessing be prevented through the original manufacturer’s intellectual property rights?
What impact will the reprocessor’s product liability have on the reprocessing business?
How will original manufacturers react to increased liability risks caused by reprocessing?
More powers awarded to notified bodies in relation to carrying out conformity assessment procedures and post-marketing surveillance obligations, however, increased scrutiny of these notified bodies has been imposed. These new obligations raise questions as to:
Will notified bodies be able to meet the new stringent requirements and will they be on time?
How will the increased scrutiny of notified bodies impact manufacturers?
What will be the impact of CJEU case, C-219/15, on the responsibility of notified bodies?
There is no significant change surrounding the use of hazardous or potentially hazardous substances in medical devices or in in vitro diagnostics, but imposition of some duties to inform the users appropriately in cases where exposure to hazardous substances is likely and specific guidance is forthcoming on the use of certain hazardous substances such as phthalates.
New transparency provisions were introduced including a mandatory unique device identifier system, facilitating the traceability of devices, as well as an enhanced EUDAMED, including the obligation to publish clinical investigation reports and a summary on EUDAMED. These provisions raise the following questions:
Will manufacturers be prevented from bringing new and innovative products to market as their data would be easily accessible by competitors?
Will more Medtech companies go down the pharma-route and increase patent filings? Would there be a need for SPCs for MDs?
How will the roll-out of EUDAMED, including the unique device identifier-database, which differs from the normal transposition regime, influence a manufacturer's implementation planning?
The implications of Brexit will depend on the type of model which will subsequently be adopted by the UK, either joining the EEA or the European Free Trade Association or leaving the European Committee for Standardization.