Main changes introduced by the MDR for Class I Device Manufacturers
All medical device companies will be affected by new developments under MDR, which comes into effect on 26th May 2021. Everyone operating in the medical device sector will be affected one way or another - Manufacturers, Importers, Distributors, and even Notified Bodies.
Even though Class I Medical Device manufacturers have only to undergo a self-notification process (as they did under the Medical Device Directive), here are the top 5 fundamental changes being introduced by the MDR:
1. Changes in Medical Device Classification Rules
A number of changes are presented in the product classification, with one of the main changes being introduced by Rule 11, which mentions Software As a Medical Device (SAMD).
According to this rule, computer programs that assist or help in a diagnosis are no longer considered Class I, and instead, they are now considered as at least Class IIa. All manufacturers must justify the class of their product following the rules established by the MDR. (Expert Advice? Call Us Now!)
2. Pre-marketing guarantees:
MDR reinforces product risk regulation by scrutinising conformity assessment and demands more clinical information in the technical file.
Certain changes have been introduced in the clinical evaluation of products (including Class I devices), which manufacturers must carry out independently of the product classification.
The clinical evaluation of Class I products
- must be demonstrated through tests and technical-scientific literature, and
- their documents updated after assessment of general safety and performance requirements and risk analysis.
Manufacturers need to update the product label with information on Instructions For Use (IFU) and information regarding the modification of the Declaration of Conformity.
3. Post-marketing guarantees
The MDR methodically reinforces post-marketing monitoring systems where all manufacturers, regardless of the classification of their products
- Must have a post-marketing monitoring system in place, and
- Provide information on the safety and performance of their devices.
4. Increased transparency and traceability
To increase transparency and traceability, the MDR has brought in
- A European register of economic operators (manufacturers, authorised representatives, and importers) as well as products, and
- A unique device identification system (UDI). In due course, all manufacturers must obtain their UDI codes and register the products and actors (distributors) with EUDAMED.
5. Extension of the obligations of economic operators
Some significant changes are being introduced where Economic Operators will play a vital role.
Medical Device Manufacturers must:
- have a Quality Management System (QMS) in which all the processes involved in the life-cycle of a medical device must be implemented.
- appoint a Person Responsible for Regulatory Compliance (PRRC) who is "permanently and continuously at their disposal". This is an entirely new and mandatory role created by the MDR.
If you are a Manufacturer of a Class I Medical Device, you do not need to be worried about these changes because our Experts are here to help.
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