Medical Devices
Medical devices are essential for delivering good care. The definition of medical devices is very broad and ranges from wheelchairs and plasters to implants and CT scanners. Software and health apps may also qualify as medical devices. The quality, security and access to the market of medical devices are enshrined in national and European laws and regulations. These legal rules apply to manufacturers, importers, distributors and agents, among others.
Implementation of Medical Devices Regulation
Due to the corona pandemic, there has been a postponement of the implementation date of the Medical Devices Regulation or “MDR”, which will replace the Medical Devices Directive from 1993. The MDR is now expected to enter into force on 26 May 2021. The date when the new In-Vitro Diagnostics Regulation (“IVDR”) will enter into force remains 26 May 2022. Eline Lam has prepared a handy overview of the main changes the MDR will bring for manufacturers, distributors and health care institutions. You can download this overview here.
Health Care Team
Fenna van Dijk and Eline Lam have a thorough knowledge and experience in the field of medical devices. The team advises on questions about access to the market, licences, clinical research, and questions about inducements, labelling and advertising. They assist manufacturers of medical devices in drafting contracts with customers, or with doctors who cooperate with the manufacturers. For an overview of their recent work, see 'Recent Work' at the bottom of this page.
A special feature of the Health Care Team is that they can offer advice on medical devices from various perspectives. Fenna and Eline work closely together with the specialists in the Commercial & International Trade Team as far as international products of medical devices manufacturers are concerned. Our Insurance and Liability practice group advises and litigates regularly about product liability. Besides, our Insurance and Liability specialists offer a special service in the field of product recalls. We will cooperate with our colleagues from the IT practice group if we are dealing with the interface of software, artificial intelligence and medical devices. Moreover, we also cooperate closely with the Life Sciences team where the regulatory framework of medicines and cosmetics is concerned. In matters concerning tendering procedures for medical devices, we cooperate with our Public Procurement team.
International Comparative Law Guide
Fenna van Dijk and Eline Lam have contributed to the International Comparative Law Guide – Drug & Medical Device Litigation.
This publication is relevant to you if you are dealing with:
- The development of medical devices, medicines and cosmetics;
- Questions from supervisory bodies;
- The impact of advertising codes on your business operations;
- The effect of the GDPR and other privacy regulations;
- The performance of clinical trials;
- Recalling a defective product (product recall).
The special focus of this publication is on product liability and claims.
You can find the publication in English on the website of ICLG:
Recent Work
- Advising a Dutch non-governmental organization about an app produced by them in light of the regulations under the MDR.
- Advice about the qualification of software and applications of artificial intelligence as medical devices.
- Assessing agreements of suppliers of medical devices and hospitals.
- Advice about a tendering procedure for the purchase of medical devices.
- Drafting agreements with doctors and advice about incentives.
- Advice about labelling of medical devices, medicines and cosmetics.
- Drafting general terms and conditions for a manufacturer of medical devices.
- Guidance of restructuring operations and acquisitions of international manufacturers of medical devices.
- Guidance of the construction of new housing for a manufacturer of medical devices.
Market recognition
The Legal 500 EMEA 2020 - Healthcare & Life Sciences - Ranked
At Kennedy Van der Laan, Fenna van Dijk assists healthcare clients with corporate matters, and IP specialist Maarten Schut advises on a range of issues in the life sciences arena including R&D collaborations, licensing work and the protection of trade secrets. The team also acts for its healthcare clients on mergers, the establishment of joint ventures, medical liability cases, disciplinary actions and data protection mandates.
Chambers Europe 2020 - Healthcare - Ranked
What the team is known for
Experienced team advising on a range of corporate matters, including joint ventures, acquisitions and governance issues. Additionally assists with contracting matters. Further experience acting for start-ups on the establishment of their businesses. Predominantly represents healthcare providers.
Strengths
Clients observe that the team is "very knowledgeable and practical."Additionally clients highlight that the group is "result and client-oriented."
Notable practitioners
Fenna van Dijk frequently acts for healthcare providers on a range of corporate matters, including acquisitions, joint ventures and governance structures. Additionally assists clients with market entries, contractual and compliance matters.
The Legal 500 EMEA 2019 - Industry focus: Healthcare and life sciences - Ranked
Kennedy Van der Laan has a special focus on mergers and joint ventures together with medical liability and disciplinary actions. The team is a member of Biolegis, the pan-European network of independent law firms with a focus on life sciences. Fenna van Dijk heads the healthcare team and Maarten Schut specialises in IP within the life sciences sector. Meltem Koning advises on corporate and private equity matters. The group advised the Oncode Institute, a new ‘super’ institute combining oncology research from numerous academic hospitals and research institutes. It assisted with its set up and governance, funding negotiations, and complex IP arrangements. In other work includes advising on licensing, R&D collaborations, and patent disputes.
Chambers Europe 2019 - Healthcare Department - Ranked
What the team is known for
Represents clients in medical liability claims and disciplinary cases, as well as advising health institutions on mergers, joint ventures and investments in the healthcare sector. Additionally advises on governance and compliance mandates. Also acts on matters of confidentiality and data protection. Further experience advising start-ups on the establishment of their business in the Netherlands.
Strengths
Clients praise the lawyers' "accessibility and customer-oriented attitude," going on to add: "They provide tailor-made solutions that match our demands."
Work highlights
Advised Oncode Institute on funding arrangements and affiliation agreements with partner institutes following its establishment.
Notable practitioners
Interviewees admire Fenna van Dijk for her "personal touch and real commitment." She acts on a range of corporate mandates relating to the healthcare sector, including mergers, joint ventures and the establishment of institutions. Clients also praise her governance work, saying: "She understands complex issues and gives the most appropriate answer to questions quickly and efficiently."