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4 significant things expected from the new EU Medical Device Directives
If all goes to plan, in the coming weeks, the EU Medical Device Directive will be agreed upon by European politicians.
The ‘trialogue’ discussions between the European Commission, the European Parliament and the Council of Ministers are expected to be concluded within the next few weeks.
If all remains on schedule, the administrative effort of translating the regulations into all European languages will begin. This is expected to take until the end of 2016.
Following that, the new EU MDR (Medical Device Regulation) and IVDR (In-Vitro Device Regulation) will come into effect under a three year trial period for the former and a five year period for the latter.
With such a short amount of time left before the regulations begin their trial periods, let’s take some time to look at four significant things likely to come about from the new directives.
- The definitions of medical devices will be expanded considerably
Products that were previously not designated as medical devices will now fall under that description. This includes any products used for cleaning, disinfection, or sterilisation and any devices used for “control or support of conception”. This includes things like in-vitro fertilisation treatments.
Even medical devices that serve no medical purpose will be included under the new definitions. For example contact lenses are now considered medical devices under the new regulations along with the likes of liposuction equipment and lasers used for hair or tattoo removal.
It should also be noted that while in-vitro (IVD) devices are included in the definition of medical devices, later in the definition it excludes IVDs from the regulation and identifies the new regulations under the IVDR as the ones to follow.
- Probable CE marking changes will be unpopular within the industry
Eyebrows have been raised in the industry over changes in the route to CE marking of Class III implantable devices and implantable devices in general. A new addition is the ‘scrutiny process’ which requires that before a notified body can confirm the CE marking and distribute the certificate, the device must go before an expert panel.
The EU’s intention is to give oversight beyond the notified bodies but industry insiders are questioning how this will lead to delays affecting development and patients
In a recent BSI webinar, their senior vice president for healthcare solutions, Paul Brooks summed up the industry concerns quite well:
“The industry has been very concerned about the extra scrutiny of clinical data for [Implantable] Class III medical devices. They see a potential there for less predictable clearance of these devices. They have been concerned about the process for identifying the expert panels. They would much rather see the quality of the notified bodies & the competence of the notified bodies increased because they believe this new scrutiny could introduce delays to innovation and delays to benefits to patients from getting access to that new innovation,” he said.
Due to politics, he does not believe that this provision will change even with industry concerns highlighted.
- Notified bodies will continue to face scrutiny
The pressure notified bodies have been under is set to continue with the new directives.
Due to events such as the Poly Implant Prothèse (PIP) scandal in 2010 it was decided that the current system of oversight was not stringent enough. It has been tightened up since then with a number of notified bodies being de-designated and more moving away from offering CE marking services altogether.
Under the new directives all notified bodies will have to reapply to be notified bodies under the medical device regulations.
“I think we can expect to see increased scrutiny on the notified bodies going forwards and particularly on their competence, their procedures and on the oversight of the notified bodies,” said Paul Brooks.
- Clinical investigation approval to be improved
At the moment in Europe the process for clinical investigation and evaluation is rather inefficient and needs to be improved. This is being addressed by the MDR with a large variety of changes and additions to Chapter VI. The intention is to offer much greater clarity & consistency to the approval process in Europe.
An industry concern about this part of the regulation is the requirement that clinical data should only be from published peer reviewed data. The reason for concern over this is that much of the non-peer reviewed data accessible to manufacturers is still of a very high standard. On top of that, Class III devices’ clinical investigation under the new provisions, likely leading to more delays in the development process.
Even worse for manufacturers, the Class III and implantable device clinical investigations “can only rely on equivalency data from manufacturers’ own devices or from devices where manufacturer has full access to the data of an equivalent device,” according to Mr. Brooks. For obvious reasons this has caused upset as Class III regularly draws equivalences to competitive products where the manufacturers do not have access to all the clinical information. EUDAMED database will be used to register all future clinical investigations once the MDR comes into force.
With so many elements to the new regulations and with so much still unconfirmed we can only scratch the surface in a short article like this but we hope it has given you an idea of the kinds of things that will be impacting our sector in the near future.
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