Medical Devices

Phenomenal medical

devices lawyers advising

on the legal and regulatory

aspects of your medical

devices.

The amazing medical devices lawyers will advise and assist you with achieving compliance under the Medical Devices Regulations if you are distributing or supplying medical devices, accessories for medical devices and products in the UK or you intend to place or make them available on the UK market. Our medical devices solicitors will ensure that your medical devices have been designed and manufactured in accordance with the requirements of the Medical Devices Regulations if you are a manufacturer placing your medical devices on the market or putting them into service.

A ‘Medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease;
diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability;
investigation, replacement or modification of the anatomy or of a physiological or pathological process or state
providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations; and
which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means;
devices for the control or support of conception;
products specifically intended for the cleaning, disinfection or sterilisation of devices.

Whereas, medical devices that are manufactured and used within health institutions are described as being put into service.

Product Classes

Class I
Clas IIa
Class IIb
Class III

Our Services

Clinical Investigations	Clinical Trials
Manufacturers	Advice and assistance with compliance of Medical Devices: When placing medical devices on the market or putting them into service As to whether the medical devices have been designed and manufactured in accordance with the requirements of Medical Devices Regulations Results of Clinical Evaluation Conformity Marking your Device CE marking Notifications Technical Documentation UDI system Claims Classification Label Claims Labelling & Packaging Surgical Face Masks, Surgical Gloves, Standalone Software and Apps Risk Based Classification Software Sterile Conditions Traceability Getting your Device Certified Registering your Device with the MHRA UK Responsible Person
Distributors and Importer	Advice on the Obligations of a Distributor or Importer Advice and assistance with Compliance Technical Documentation Changes to pack sizes Classification Label Claims Labelling & Packaging Modification of Medical Devices Repackaging Safety Conformity
Borderline Products	Evaluation and Advice on Borderline Cosmetic Products as Medical Devices
Products which combine a Medicinal Product or Substance and a Medical Device	Evaluation and Advice on Medical Devices with both a Medical and a non-Medical Intended Purpose Marketing Authorisations
Products similar to Medical Devices	Evaluation and Advice on Products where the Manufacturers Claim only an Aesthetic or another Non-Medical Purpose, similar to Medical Devices in terms of Functioning and Risks Profile
Regulatory	CE marking Conformity Post-marketing Surveillance Registration UK(NI) indication: General Medical Devices Verification

Articles

Manufactured Goods
- Placing manufactured goods on the EU and UK internal markets-no deal Brexit guidance, March 2019

Medical Devices
- Regulation of Medical Devices, September 2018

Related Services

Testimonials

DNA Diagnostics Centre

‘We really appreciated RT Coopers professional expertise regarding a project they assisted with. Detailed and structured feedback was crucial and very important to our innovative concept. I will definitely revert back to Rosanna and the team on other projects in the near future.’ Daniell Leigh, Director

Ice Healthcare Ltd

“RT Coopers Solicitors operate in the real world and deliver what they say they’ll deliver. A highly responsive, straight talking, client focused team who will pull out all the stops to deliver on-time results of the highest standard. Definitely a team you want along side you when the going gets tough. I think that says it all…...” Janet Dean, Operations Director

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