Quality Risk Management ICH Q9 – Revision published for public comments
Medical Device Regulation implementation – One year to go!
As highlighted in our recent article “ The Medical Device Regulation and COVID-19” the date of application of the MDR has been delayed by 1 year, from the 26th May 2020 to the 26th May 2021. As this delay was only agreed in April of this year, the majority of device manufacturers will have been well underway with their MDR transition preparation. By now, most, if not all manufacturers will know if the new device classification rules will impact their products. They should also have prepared for the change in the rules for claiming equivalence, and obtained additional clinical data where needed, in the cases where the original device technical file is not available. Clinical Evaluation Reports are being updated and Post-Market Surveillance Systems have been created.
However, there are some subjects which may seem less critical or are less obvious, but that also warrant significant time and consideration:
- Unique Device Identification – whilst the Eudamed database has been delayed until 2022, so no device registration is required, and the UDI does not need to appear on the labelling until 2021-2025 depending upon classification, the UDI and Basic UDI-DI still need to be included within the Technical Documentation. Management of UDI requires cross-organisational cooperation, so we recommend that discussions are started soon, if they have not already.
- QMS – Many manufacturers assume that if they are complaint with ISO 13485:2016 that their Quality Management System will meet the requirements of the MDR. However, there are a number of requirements listed in Article 10 of the MDR (General obligations of manufacturers) that are not included in the QMS standard. Examples include strategy for regulatory compliance, UDI verification and handling communication with stakeholders.
- Restricted substances – MDR and RoHS Directive (Restriction of the use of certain Hazardous Substances Directive 2011 / 65 / EU need to be complied with. Both include substance restrictions, but the approaches used are very different. The MDR Annex I section 10.4 requires substitution of carcinogens, reproductive toxins and mutagens (CMR) of category 1A and 1B as well as endocrine disrupting (ED) substances, of which the EU has two classifications, 1 and 2, unless the manufacturer can show that the use of the substance is justified from a benefit-risk analysis. The scope of these requirements is limited to materials that come into contact directly with patients or in contact with solids, fluids or gases that are administered or re-administered to patients.
- Economic Operators – The MDR identifies a number of Economic Operators, and their responsibilities are covered in articles 10-16. Depending upon the location of the manufacturer, there may be a necessity for new agreements to cover the MDR and the new requirements and liability. Multinational organisations should also pay attention, that whilst they may not need an external Authorised Representative or Importer, if the Legal Manufacturer is based outside of the EU, it is expected that the required verification to be completed by the AR and Importer are still carried out.
The team at Pharmalex are ready and able to assist with all Medical Device activities, whether they relate to QMS challenges, Technical Documentation preparation or understanding the implications of the requirements of the MDR. Please contact us – contact@pharmalex.com
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