May 19, 2021
Under the MDR, whose final Data of Application is May 26, 2021, Class I device manufacturers will face new requirements in terms of self-certification and compliance. The EC factsheet covers classification, declaration of conformity and related issues pertinent to these companies.
The factsheet covers Class I devices currently marketed in Europe under Medical Device Directive 93/42/EEC, as well as new devices to be commercialized under the MDR.
Quality management system work
First, manufacturers should properly integrate applicable MDR provisions into their existing quality management systems (QMS).
Meeting MDR “medical device” definition
Second, manufacturers should confirm that their products do indeed qualify as medical devices according to definitions set by the MDR.
Class I classification
Next, manufacturers should refer to Annex VIII of the MDR to determine whether their products qualify as Class I devices under the new Regulation.
Technical documentation preparation
Next, manufacturers of Class I devices should compile and prepare technical documentation necessary to demonstrate that their devices meet MDR Annex I requirements regarding applicable general safety and performance.
In addition, manufacturers must build out conformity of their devices to requirements according to Annexes II and III of the MDR regarding technical documentation.
Technical documentation should include data from clinical evaluations performed to support safety and performance claims, as well as safety and performance information such as labeling, packaging and instructions for use.
At this step, manufacturers should also determine whether their devices are sterile (Class Is), have measuring functions (Class Im), or are considered reusable surgical instruments (Class Ir). In any of these cases, firms will require input from Notified Bodies.
MDR Article 10 compliance
Then, companies should demonstrate compliance of their devices to MDR according to Article 10 of the Regulation, which covers general obligations of manufacturers.
EU Declaration of Conformity
Next, manufacturers should self-certify their Class I devices for CE Marking, in compliance with MDR Annex V.
Following CE Mark certification, manufacturers should register themselves as well as their devices in the Eudamed medical device and IVD database.
Once their devices are on the European market, manufacturers must meet ongoing post-market obiligations:
- Reviewing data and experience acquired via post-market surveillance (PMS) activities.
- Reporting any serious incidents and field safety corrective action (FSCA) to appropriate European Competent Authorities, as well as conducting any necessary investigations.
- Taking any necessary actions in cases where devices are found not to be in conformity with the MDR.
Manufacturers should refer to the full factsheet for additional information on European Authorized Representation, Unique Device Identification (UDI) and other requirements.
Learn more about EU MDR compliance at Emergo by UL:
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