by Kristina Holst, BDS and Dr. Sunni Patel
News came in that there was confirmed agreement on the new rules to be placed upon medical devices and in vitro diagnostic medical devices to ensure “they are safe and allow patients to benefit from innovative health care solutions in a timely manner”. Most likely the MDR and IVDR regulations will be finished and adopted by the end of 2016 and enter into force by Q2 2017 , but what does this mean for medical device companies moving forward as of today?
“This agreement matters to all citizens: sooner or later all of us enter into contact with medical devices to diagnose, prevent, treat or alleviate diseases… It will also ensure a level playing field for the 25,000 medical devices manufacturers in the EU, many of which are SMEs and which employ more than half a million persons”, said Edith Schippers, Minister of Health of the Netherlands and President of the Council.
The new rules will strengthen the surveillance of the notified bodies by national authorities and give the bodies the right and duty to carry out unannounced factory inspections and testing of samples. The notified bodies must also be re-accredited. Altogether this means a bigger burden on the bodies and as the number of notified bodies currently drops, resources may be critical especially during the transition period.
The draft regulations establish explicit provisions on manufacturers’ responsibilities for the follow-up of the quality, performance and safety of devices on the market. Manufacturers and other economic operators will have clear responsibilities, for instance on liability, but also on registering complaints on devices. There will also be high demands on post-market monitoring including annual updates of Clinical Evaluation Reports (CER). This will provide for increased transparency for both users and patients as a majority of this data will be accessible through a new database. Therefore, it appears that the efforts required by manufacturers to review their processes in order to remain compliant with the new rules will be significant.
A central database will also be set up to create an improved system for all relevant information. It will cover economic operators, notified bodies, market surveillance, vigilance, clinical investigations and certificates. This new database will provide patients, healthcare professionals and the public with comprehensive information on products available in the EU. As the database will do away with diverging national registration requirements it is said to reduce the administrative burden on manufacturers.
Another area that will be significantly changed is what is provided as clinical evidence, including stringent and robust clinical evaluation, post-market clinical follow up, and clinical investigations as current clinical requirements will be aligned with the clinical regime of medicinal products. However, it is not clear how the GCP standards will be reconciled with the proposal as there are some contradictions compared to the device standard (ISO 14155:2011). One thing that does seem clear though, is that the requirements for clinical evidence will increase and this will require companies to engage with external knowledge in both regulatory affairs, GCP and clinical investigation and look for long-term internal resources to meet these skill areas.
As some groups of devices will be up-classified, manufacturers will need to analyse their devices on the market against the new classification rules, and, if new conformity assessment is found to be necessary for a device, a transition plan will be needed. The technical assessment of class IIb implants will be according to class III requirements meaning that Class IIb implants will be up-classified to class III. According to the new rules, class IIb and class III devices, such as implants, may undergo an additional check by an expert panel on a European level before they are placed on the market, and this may indeed result in increased time to market.
Medical devices, new EU rules: all products to be phased into the new system by a three year transition periodClick to tweet
The EU will require all products on the market to be phased into the new system by the end of the three year transition period. To be prepared, companies may start to verify device status by analysing the definitions of their Medical Devices and In Vitro Diagnostic Devices. A specific focus on analysing products that are currently not included in the directives is recommended as they may fall within the scope of the new rules. Companies may also verify the risk status of their devices as this can be found in MEDDEV 2.4/1. Thereafter a gap assessment can be performed based on the new device status and risk class for the device. It is a good idea to download the regulations and annexes of the September 2015-version of the proposal. By preparing as above, companies can verify the results of their analyses when the first reading version of the new directive is published and then during the transition period review internal processes for vigilance and post-market surveillance to be prepared in time for the new reporting requirements. There will be a greater need for expert resources to navigate the new system and requirements. Initially this can be managed by consulting external experts. However, in a long term perspective companies will need to invest in staff who are knowledgeable in regulatory affairs, GCP, and clinical investigation .
Regulations and annexes of the September 2015-version of the MDR and IVDR regulations proposal
Annexes – Proposal for a Regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 – Annexes