BSI Compliance Navigator Bi-weekly Blog: New product development
New product development
The requirements of the Regulation will inevitably lead to changes in your procedures for design and development. Design and development plans will need to be adjusted to:
- address the increased requirements for clinical evidence;
- avoid or justify the use of hazardous substances and keep upto-date information on the substances that are categorized as such;
- generate recommendations on any postmarket clinical followup that might be needed; produce the summary of safety and clinical performance for class III and implantable devices and make this publicly available;
- produce a summary of clinical investigation that is easily understandable by the intended user and make this publicly available; and
- ensure consistency between the risk management plans, determinations of risk and benefit, clinical evaluation reports, post-market surveillance plans and technical documentation
The product in your research and development pipeline and their development plans need to be reviewed to assess the impact on your ability to launch these products, the effect on the development and launch timelines, and any additional needs for the development plan. The questions above for the current portfolio are also relevant to products in the development pipeline, in addition to the following.
- What is the launch timeline for products in the pipeline? For products that are scheduled to launch in the transition period for the Regulation, do you intend to launch under the existing provisions and then transition to CE-marking under the Regulation or CE-mark directly under the Regulation?
- Do you have any novel, class III implantable devices or class IIb devices intended to administer a medicinal substance? As these will be subject to the new procedures for clinical evaluation consultation (scrutiny procedures), how will this affect the development plan and timelines for approval?
- Do you conduct clinical investigations in the EU?
- Is your sponsor of a clinical investigation established in the European Union or is there a legal representative in the European Union responsible for ensuring compliance with the sponsor’s obligations? Do you have a process to confirm that:
- the device conforms to the general safety and performance requirements apart from the aspects covered by the clinical investigation; and
- every precaution has been taken to protect the health and safety of the patient(s) taking part? Is this confirmation recorded?
- Does the cost of implementing changes to the design and development plan affect the return on investment and commercial viability of the design and development project?
This blog post is an excerpt from our latest whitepaper: Implementing the European Union Medical Devices Regulations. Please download the full whitepaper to find out more information.
The Compliance Navigator blog is issued for information only. It does not constitute an official or agreed position of BSI Standards Ltd or of the BSI Notified Body. The views expressed are entirely those of the authors.
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