Why you need to continuously identify regulatory changes
a) Legal requirements
The MDR requires manufacturers to include a “strategy for regulatory compliance, including processes for identification of relevant legal requirements”. You should note, this means processes!
ISO 13485:2016 even states in its preamble that it expects that “the organization [...] identifies its role(s) under applicable regulatory requirements, [and] incorporates these applicable regulatory requirements within its quality management system”.
In Chapter 5.2, it requires as follows: “Top management shall ensure that [...] applicable regulatory requirements are determined and met.” Pursuant to Chapter 5.6.2, the management review must "incorporate applicable new or revised regulatory requirements".
b) Potential consequences
If manufacturers fail to keep up to date with these regulatory changes, they may face:
- Non-conformances in the audit, revocation of the certificate in the worst case
- Non-compliant products, which may result in legal consequences
- Issues with marketing authorization and therefore delays in the marketing of products
What you need to do as a manufacturer
New standards, laws, directives, guidelines, and regulations are published almost every day. Most manufacturers feel they can barely keep up to date. With all this information, you feel overwhelmed when it comes to
- searching and finding (you first need to know where to look)
- reading (some are hundreds of pages long)
- understanding (for example, legal wording)
- assessing whether it is relevant for your own company and products
- and determining the necessary conclusions (does a Regulatory Manager know what a new technical standard entails?)
For example, you need to adapt procedure instructions, change product specifications, perform gap analyses, reschedule approval procedures, or repeat tests with changed parameters.
Regulatory Radar takes over this information processing cycle.
How Regulatory Radar reduces the manufacturers’ workload
Regulatory Radar takes over your tasks: Instead of searching, reading, and assessing regulations yourself, this update service proactively informs you.
You automatically receive a report with the following content:
- Overview with the exact regulatory changes that are relevant to you
- Summary of the changes and the content of new regulations
- Recommendations for action
How to improve compliance and reduce costs and expenses
Regulatory Radar not only reduces your workload. This service also supports you by improving compliance efforts while saving costs. This is made possible for the following reasons:
- Cost reduction by leverage
You benefit from the fact that the Johner Institute conducts research for a large number of companies, which practically share the costs. The Johner Institute transfers this cost saving to you.
- Cost reduction by automation
The Johner Institute has developed bots that search across all sources for changes on a daily basis. This automation saves the manual effort and therefore costs, which translates into lower costs for you.
- Time savings by targeted information
Unlike newsletters, Regulatory Radar provides exactly the information that is relevant to you on a silver platter. This means that you do not have to filter out the crucial information you need. Regulatory Radar does not simply report changes. Rather, you will understand how the changes affect you and how you should respond to them.
- Higher likelihood of finding all relevant reports
The reliable bots and the many consultants at the Johner Institute work together to gather and assess the information. This increases the likelihood that all new and changed regulations can be found much more effectively than a person could do alone.
- Conformity confirmed by the ISO 13485 certificate
The Johner Institute is certified according to ISO 13485. This ensures you are compliant since the regulatory update is an outsourced process.
The Johner Institute's consultants ensure the completeness and quality of the reports. They research for you, proactively and continuously, all public sources – and some non-public ones – to scout new and changed regulations. These are the same experts who
- work as consultants to support hundreds of manufacturers and their suppliers in developing and launching on the market their medical devices quickly and in accordance with the law.
- work as (lead) auditors at notified bodies and therefore know exactly how quickly and how strictly the new requirements must be implemented.
- work as members of standards committees and have an overview of future developments, so you can organize manufacturers in good time.
The consultants who prepare the reports for you are fully aware of the regulatory changes and can propose precise recommendations on how to respond.