Gert Bos, a leading spokesman on behalf of European notified bodies, is leaving BSI Group to join global regulatory consultancy firm Qserve Group as executive director and partner. This change comes as device and diagnostics companies prepare for big changes in EU regulations. IDDM asked Bos about the timeline for the upcoming changes, as well as what companies can do to prepare.
IDDM: What do you see as the biggest impediment for manufacturers to remain in compliance as they prepare for the big changes related to regulations?
Bos: The impact of the new regulation will be quite different for manufacturers under the medical device regulation (MDR) and the in vitro diagnostics regulation (IVDR). Under MDR, the most likely outcome will be the demand for much more clinical data derived from the product of the manufacturer itself, so an end to market entry based on equivalence for high-risk devices and lower risk implants.
Evidence of such will be transparent in public summaries of clinical evidence, as well as annual reports on postmarket surveillance reviews and trend analysis, and may well be questions in formal scrutiny procedures. With this added transparency on data and increased central oversight, there will be no escape, and much more clinical data will need to be gathered.
For IVDR, this highlights the ambiguity currently still present around the requirements that are being worded towards clinical performance and postmarket clinical performance follow up. As these new requirements are not well defined yet, interpreting them in preparation of getting into compliance is a difficult task.
The second biggest impediment would be ensuring to have enough resources internally, supported by external experts and subcontractors, as well as securing resources in their notified bodies available for reviews and audits.
IDDM: How is the trilogue progressing?
Bos: Since Oct. 13, four political trilogues and six technical meetings have been held, with one or two political trilogues and a technical meeting to go before Christmas. The trilogues are reported to make some progress, whereas speed in the technical meetings is said to be low.
The upcoming Dutch presidency is preparing for the remaining trilogue and technical meeting to be held in the first four or five months of 2016. Negotiations have been split into four parts, the last of which deals with key topics such as (special) notified bodies and market surveillance, essentials from the Dali Action Plan following the PIP scandal in 2012. Any agreement reached until then is only preliminary, as only when in the last trilogues an agreement is reached will the final consensus be definitive. Until then, positions may change in further negotiations on upcoming topics. The target now set is an ‘early second reading agreement’ in the middle of June 2016.
IDDM: What is the single most important piece of advice you can give industry as it prepares for the changes resulting from the regulations?
Bos: I would say the most important thing is to ‘stay calm and make the transition.’ At this stage, that means start making a strategic assessment on impactful changes for your company and product portfolio, making a gap assessment between current compliance levels and future expectations. Based on that work, make a priority plan if a larger number of products are involved. Compliance building then should focus on getting evidence in place for priority files first, as well as starting the generation of data for second tier products if the gap assessment reveals long-term data collection will be needed. For larger portfolios, discussion might focus on which products to transfer, and which ones to fade out. To make this transition happen smoothly, timely budgeting for internal and external capacity will be of essence, as is an early start in analysis, way before the regulation is finalized and published.