Medical devices are health products that are governed by strict regulations. As a consequence of the entry into application on 21 May 2021 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, their regulations are in constant evolution.
The texts of the French Public Health Code concerning medical devices (articles L5311-1 et seq) will eventually also be impacted by the entry into application of these European regulations.
As a result, manufacturers, representatives, importers and distributors of medical devices must adhere to the whole range of current regulations during all stages of the development of medical devices, a task which is made easier with the help of a lawyer specialising in medical devices.
Assistance throughout all stages of a product's life cycle
The firm offers help and advice to medical device manufacturers in drafting and negotiating all agreements related to medical devices during all stages of their life cycle:
upstream: all agreements necessary for the design and manufacture of medical devices.
downstream: all agreements necessary for the sale of medical devices.
product-level: agreements with other manufacturers that own medical device systems or equipment, regulations concerning the health data generated by the medical device.
1 - Agreements or general conditions for medical devices
Agreements relating to the supply of medical devices: R&D, industrial outsourcing, shaping, contract manufacturing, purchase and supply.
Agreements relating to the sale of medical devices: distribution, sales representatives, promotion, co-promotion and co-marketing.
Partnership and/or cooperation agreements.
General conditions of sale and use, mainly for online points of sale.
Agreements relating to industrial property: licensing (out-licensing and in-licensing), assignment, technology transfer, depositing Soleau envelopes, confidentiality or secrecy agreements (NDAs).
Agreements relating to setting up clinical trials: with CROs, relationships with research ethics committees, single agreements.
Agreements and relationships with healthcare professionals.
2 - Advice on regulations
Determining the legal definition of health products (borderline products).
Application of advertising legislation.
Implementation of ownership transparency legislation and the French anti-gift law (DMOS).
Regulatory assistance throughout clinical trials.
Assistance adapting to French and foreign health authority regulations
3 - Advice on health data
The services we offer in this area can be found on this dedicated page on our website.
4 - Disputes
Unfair competition disputes regarding the violation of medical device advertising regulations.
Disputes relating to copyright infringements of medical devices.
Appeals against health authority rulings (appeals to higher authorities, legal appeals, cases before administrative courts).
Defective product and medical device liability.
