FIT*: Fast Implementation of MDR-Transition
Full service for legacy devices during the MDR transition periods
With the publication of Regulation (EU) 2023/607 of the European Parliament and of the Council of March 15, 2023—amending Regulations (EU) 2017/745 and (EU) 2017/746 with regard to transitional provisions for certain medical devices and in-vitro diagnostics—on March 20, 2023, manufacturers of legacy medical devices (legacy products**) benefit, under certain conditions, from significantly extended MDR transition periods.
Is your product eligible for the extended MDR transition periods?
What steps need to be completed in order to achieve MDR compliance?
We support you with the en.co.tec FIT program through every step on the way to MDR compliance within the required deadlines!
Our offer in detail
Step (1) Assessment of the applicability of the MDR transitional periods:
If you wish, we can use the en.co.tec FIT* program to assess whether your product qualifies for the extended MDR transitional periods. → Euro 310 (excluding VAT)
Step (2) Find a Notified Body (in the case of higher-classified Class I products):
If you wish, we can support you with the en.co.tec FIT* program in finding and applying to a suitable Notified Body², provided your legacy products** fall under category (b). → Euro 750 (only in combination with Step 1) (excluding VAT)
Step (3) Higher-classified Class I products only:
If you wish, we can provide fast and professional support with the en.co.tec FIT* program for the implementation and certification of ISO 13485. EN ISO 13485:2016 / A11:2021-09, as a harmonized standard, forms the basis for the quality management system required by the MDR [MDR Art. 10(9)]. → Price on request.
Step (4) MDR Gap Assessment and / or MDR Mock Audit:
If you wish, we can provide fast and professional support with the en.co.tec FIT* program to identify the gaps in your quality management system that need to be closed in order to achieve MDR compliance. → Euro 3,770 (excluding VAT)
Step (5) Implementation of MDR:
If you wish, we can assist you with the en.co.tec FIT* program to make your quality management system MDR-compliant by 26 May 2024 and, if desired, also take care of the application process with the Notified Body². → Price on request.
Take advantage of this offer to systematically and in a timely manner
manage the MDR transition!
Legacy product**
Medical device that is placed on the market after the entry into force of the MDR (i.e., after May 26, 2021) in accordance with the transitional provisions of the MDR.
- (a) Class Is/m, IIa, IIb, III products for which a certificate was issued by a notified body in accordance with the MDD or AIMDD before May 26, 2021.
- (b) Up-classified Class I products for which the conformity assessment procedure under the MDD did not require the involvement of a notified body and for which the declaration of conformity was issued before May 26, 2021, provided that
► the conformity assessment procedure under the MDR requires the involvement of a notified body. - Examples:
- Reusable surgical instruments (I→ Ir)
- Medical device software (I → IIa,b oder III)
- Substance-based Medical Devices (I → IIa,b), u.a.
Notified Bodies²:
For example: TÜV Süd Produkt Service, mdc, bsi, SiQ, QMD
Do you need support with the transition from MDD to MDR for your medical devices? Then get in touch with us! We look forward to seeing you!
