MDR Information for Distributors

As part of our mission to improve people’s lives through our health care products, Bausch Health continues to invest in product innovation, its people and the systems required to grow the business and to adapt to ongoing changes in regulatory requirements.

Stakeholders in the health care supply chain will be aware that the European Medical Device Regulation 2017/745 of April 5th 2017, (“EU MDR”), will become applicable on May 26th 2021 in all EU Member states.

Bausch Health has committed significant resources to ensure the compliance of their medical devices and associated quality systems in anticipation of the date of application (May 26th 2021) and will continue to build on the progress made for the remainder of the transition period through May 2024.

As part of its strategy for compliance to the EU MDR, Bausch Health has engaged with its notified bodies and extended most of its medical device certificates under the Medical Device Directive, 93/42/EEC, as amended subsequently and will continue to make product available to EU markets in accordance with the transitional provisions outlined in Article 120 of the EU MDR.

The company is aware of the new obligations incumbent upon other economic operators within the supply chain and is ready to support their trade partners and customers by making available essential information to allow the undertaking of new duties. If you identify as an importer or distributor within the EU that makes available Bausch Health medical devices from any of its subsidiaries* , please contact your local commercial or customer services representative for any product related information needed in support of your activities which are outlined in Chapter II of the EU MDR and in particular Articles 13 and 14 thereof.

Bausch Health looks forward to making a difference by embracing the enhancements brought about by the new regulation and working with our partners to ensure the continuity of supply of exceptional products to our customers.

*The following Bausch Health subsidiaries manufacture medical devices for the EU market:

Bausch & Lomb Inc.
1400 N Goodman Street, Rochester NY 14609 USA

Bausch & Lomb GmbH
Im Schuhmachergewann 4, 69123 Heidelberg, Germany

Dr. Gerhard Mann Chem.-Pharm. Fabrik GmbH
Brunsbütteler Damm 165/173, 13581 Berlin, Germany

Bausch & Lomb GmbH
Brunsbütteler Damm 165/173, 13581 Berlin, Germany

ICN Polfa
(35-959), 2 Przemyslowa Street, Rzeszόw, Poland

Valeant Med Sp z.o.o,
Ryzowa Street 31, 02-495, Warszawa, Poland

Technolas Perfect Vision GmbH
Messerschmittstraße 1+3 80992 München, Germany

Solta Medical
11720 North Creek Pkwy N #100, Bothell, WA 98011, USA

Synergetics Surgical
3845 Corporate Centre Drive O'Fallon, MO 63368 USA

Laboratoire Chauvin
416 Rue Samuel Morse, 34000 Montpellier, France

Bausch & Lomb IOM Spa
Viale Martesana 12, 20090 Vimodrone, Milan, Italy

Sterimedix Limited,
26 Thornhill Road, North Moons Moat, Redditch, Worcestershire, B98 9ND, UK