Team-NB has prepared a template of contractual clauses that shall be added to the Agreement that the Manufacturer has concluded with his Notified Body to be applicable in the transition period of MDR and IVDR. This is particularly relevant for the Manufacturers who will be using CE Certificates issued under the ‘’old’’ regime of the Directives after the new Regulations become applicable, but until May 2024 at the latest.
Team-NB suggests to draft an Addendum to the original Agreement, which will among others cover the following crucial points:
- Duration of the contract;
- Manufacturer’s obligations in the transition period;
- Validity of the CE Certificates;
- Interpretation of significant changes;
- Surveillance audits;
- Clause on non-renewal, non-extension, etc. of CE Certificate;
- Violation of contractual clauses.
If you wish to know more about the changes brought by the new MDR and IVDR, or if you would need our assistance with Obelis Notified Body Selection Service, please do not hesitate to contact us. Obelis Experts, having nearly 30 years of experience with EU Regulations, will gladly answer your questions.
Ajda Mihelčič