The Regulation of Medical Devices in the UK

Transcription

1 The Regulation of Medical Devices in the UK 1. What are the main requirements for a medical device to enter into the market and how are they regulated? Are there any licensing, marketing authorisation, registration requirements? In the UK, medical devices are regulated by the Medical Devices Regulations 2002 (the MD Regulations ) which implement: Council Directive 90/385/EEC (active implantable medical devices), Council Directive 93/42/EEC (medical devices) and Directive 98/79/EC (in vitro diagnostic medical devices). The MD Regulations have been amended to reflect subsequent amendments to these Directives. Further, the MD Regulations also contain the necessary measures for implementation of agreements of mutual recognition between the EU and Canada, Australia, New Zealand, and the United States of America relating to medical devices. The MD Regulations set out the minimum standards for the manufacture and marketing of medical devices in the UK. The designated body for overseeing compliance with the MD Regulations is the Medicines and Healthcare Products Regulatory Agency (the MHRA ), an executive agency of the Ministry of Health. Part I of the MD Regulations contains introductory provisions relating to all types of medical devices such as definitions, the scope of the regulations and transitional provisions. Part II of the MD Regulations applies to all medical devices, accessories to medical devices, single use combination products, and systems and procedure packs, other than active implantable medical devices (and accessories thereto) and in vitro diagnostic medical devices (and accessories thereto). Those devices are dealt with in Parts III and IV respectively. According to Part II, a general medical device may not be placed on the market or put into service unless: It meets the essential requirements set out in Annex I to Directive 93/42/EEC (regulation 8); or It or its sterile pack bears a lawfully applied CE marking (regulation 10). There are exemptions to the requirements set out in regulations 8 and 10, such as devices shown at trade fairs, custom made devices, or devices intended for clinical instigations. These exemptions are given in regulation 12. The procedures for lawfully affixing a CE marking to a medical device are set out in regulation 13 (i.e. the conformity assessment procedures) by reference to relevant Annexures of Directive 93/42/EEC. There are specific arrangements which relate to systems and procedure packs, custom-made devices and devices intended for clinical investigation (regulations 14-16). The same framework is replicated in Parts III and IV of the MD Regulations for: and Active Implanted Medical Devices: essential requirements - regulations 22 and 23; exemptions - regulation 26; conformity assessment - regulations 24 and 27; specific arrangements - regulations 28 and 29; In Vitro Diagnostic Medical Devices: essential requirements - regulations 33 and 34; exemptions - regulation 39; conformity assessment - regulations 36 and 40; specific arrangements - regulation 43. However, Part III refers to Directive 90/385/EEC and Part IV refers to Directive 98/79/EC, the relevant European legislation for active implantable medical devices and in vitro diagnostic medical devices respectively.

2 The registration of medical devices is a self-declaration process. First the manufacturer (or a person who sterilises the product before it is placed on the market) must determine whether the product: falls first within the definition of a medical device and also with the definition of a Class 1 or custom-made device (regulation 19); or falls within the definition of a system or procedure pack, and is not CE marked (regulation 19); or falls within the definition of an in vitro diagnostic medical device (regulation 42). If the product falls under one of those sections, the manufacturer (or its designated person) is required to register the device with the MHRA. Registration with the MHRA is not required if the device or pack was first placed on the market in another state which is party to an association agreement, and the manufacturer has already registered with the competent authorities of the state. The data registered with the MHRA is subsequently entered into the MHRA s public access medical devices database and the European Databank on Medical Devices (EUDAMED). 2. What are the labelling and language requirements for medical devices? Do different rules apply for different types or classes of devices, i.e., medical devices for professional and non-professional use, software devices? Is e-labelling possible? As explained in Section 1, the regulation of medical devices in the UK is governed by the MD Regulations, which includes meeting certain essential requirements. Regulation 9 sets out the factors required to determine whether a general medical device complies with those essential requirements and in particular sub-paragraph (3) details the mandatory labelling requirements by cross reference to Annex I to Directive 93/42/EEC. However, the MD Regulations specify that the essential requirements (set out in paragraphs 8.7 and 13 of Annex I to Directive 93/42/EEC) regarding information on the package or label are only complied with if the information is in English (regardless of whether it is also present in another language or whether the device is for professional use). The essential requirements concerning information which must be supplied by the manufacturer are as follows: Labelling to distinguish between sterile and non-sterile products (paragraph 8.7). Information required to use the device safely and properly (paragraph 13.1). Labelling detailing: the name and address of the manufacturer or authorised representative; words to identify the device; a batch or serial number; a use before date or if not appropriate the date of manufacture; any special operating instructions; any necessary warnings or precautions to be taken; and where appropriate the words STERILE (paragraph 13.3). If the intended purpose of the device is not obvious to the user, it must be clearly stated on the label and on the instructions for use (paragraph 13.4). The essential requirements, regarding instructions for use are only complied with if: (i) the instructions are in English or another Community language; and (ii) if the instructions are not in English, any packaging, label or insert carries a clear statement in English stating the language in which the instructions are given. The essential requirements concerning the particulars which must be included in the instructions for use are as follows (paragraph 13.6): Save for batch numbers and dates; the information referred in paragraph 13.3 (discussed above). Performances referred to in paragraph 3 and any side effects. Details of any further treatment before the device can be used. Information needed to verify whether the device is properly installed. Information on processes for re-use (if applicable). Information detailing any contraindications or precautions to be taken. Date of issue of the instructions for use.

3 The requirements for active implantable medical devices and in vitro diagnostic medical devices are dealt with by a similar framework, albeit set out in regulations 23 and 35 in Parts III and IV respectively. In the case of active implantable medical devices, sub-paragraph (3) of regulation 23 specifies the following mandatory labelling requirements: The essential requirements in paragraph 14 of Annex I to Directive 90/385/EEC, regarding information on the package or label, will only be complied with if the information is in English (regardless of whether it is in another language or whether device is for professional use). The essential requirements in paragraph 13 of Annex I to Directive 90/385/EEC, regarding instructions for operation of the device in paragraph 15 of Annex I, will only be complied with if: (i) the instructions are in English or another Community language; and (ii) if the instructions are not in English, any packaging, label or insert carries a clear statement in English stating the language in which the instructions are given. In the case of in vitro diagnostic medical devices, sub-paragraph (2) of regulation 35 details the following mandatory labelling requirements: The essential requirements in paragraph 8 of Part B if Annex I to Directive 98/79/EC, regarding information to be provided, are only complied with if that information is in English and only to the extent that the device may reach a consumer in the United Kingdom. 3. What are the main rules and principles for advertising of medical devices and interactions with health care professionals and to what extent do they differ from the ones applicable to pharmaceuticals? The MD Regulations do not cover separate advertising materials only the labelling and packaging of medical devices themselves. Advertising materials are instead regulated in part under general consumer protection legislation such as the Sale of Goods Act 1979 (as amended) and the Consumer Protection from Unfair Trading Regulations 2008; and in part under the advertising regulatory regime administered by the Advertising Standards Association ( ASA ). The latter regime is set out in two advertising codes: Broadcast advertising must comply with the UK Code of Broadcast Advertising ( BCAP Code ); with medical devices and medicines subject to the specific provisions of Rule 11. Rule 11 includes the requirements that any marketing communication must be centrally cleared before being broadcast and that marketing for any claims must be evidenced. Non-broadcast advertising must comply with the UK Code of Non-broadcast Advertising, Sales Promotion and Direct Marketing ( CAP Code ); with medical devices and medicines subject to the specific provisions of Rule 12. Rule 12 again addresses numerous aspects of marketing communications including the requirements for any claims to be evidenced, not to mislead consumers by using confusing language, and not to guarantee the efficacy or safety of products. The advertising of medicines is considerably more heavily regulated than that of medical devices and must comply with the requirements of the Medicines Act 1968 as well as the BCAP and CAP Codes. The Medicines Act requirements include compliance with regulations made under it as well as any conditions contained in the marketing authorisation, certificate, licence or traditional herbal registration for the product being advertised. Further, Title VIII of European Directive 2001/83/EC, as amended by Directive 2004/27/EC, concerns The Advertising of Medicinal Products for Human Use and has been implemented in the UK by The Medicines (Advertising) Regulations 1994 and The Medicines (Monitoring of Advertising) Regulations 1994 (both as amended). These Regulations have been incorporated into the CAP and BCAP Codes.

4 4. To what extent the pricing and reimbursement of medical devices are regulated? Under what conditions will the costs of the medical devices be reimbursed and by which competent authority? In the UK, the pricing of medical devices is not regulated, with manufacturers being free to set their own prices. However, if a device is also within the definition of a pharmaceutical product (e.g. diagnostic imaging contrast agents) then it will fall within the ambit of the Pharmaceutical Price Regulatory Scheme ( PPRS ), a voluntary agreement entered between the Department of Health and the pharmaceutical industry and renewed every 5 years or so. In essence the PPRS limits the amount of profit a company can make from sales of branded medicines to the UK s National Health Service ( NHS ) by seeking to balance the objectives of, on the one hand, ensuring the supply of safe, effective medicines to the NHS and, on the other, ensuring the pharmaceutical industry is sufficiently profitable to be capable of sustained research and development. If the manufacturer does not join the PPRS, then a mandatory statutory scheme applies. As regards reimbursement, there is no simple answer. There is no national list detailing which devices are specifically reimbursable or at what price. Instead medical devices are reimbursed through a coding system called Healthcare Research Groups ( HRGs ). HRGs are annually reviewed groupings of clinically similar treatments that use similar levels of resources. An HRG code is given to each such treatment group and that code is then used to determine the level of reimbursement that should be provided based on the resources that have been used. In addition, pass-through payments may also be available for innovative devices in certain circumstances. Where devices do not fall within an HRG, local agreements are put in place to determine their reimbursement status. 5. What are the main rules applicable to clinical trials of medical devices? The rules relating to clinical trials of medical devices are contained in the MD Regulations. Its regulations 16 and 29 set out parallel regimes for clinical trials for general medical devices and active implantable medical devices respectively. Both regimes require an application to be made to the MHRA before a trial can commence. The manufacturer of the device must, not less than 60 days before the commencement of the proposed trial, notify the competent authority of its intention to undertake a clinical trial of a non-ce marked medical device. The notification in relation to a general medical device must include a statement containing the information required by Annex VIII of Council Directive 93/42/EEC which includes: Detailed information relating to the device and manufacturer; Clinical investigation plan, investigators brochure, confirmation of insurance and documents used to obtain informed consent; Research ethics committee opinions; A statement that the device conforms with the essential requirements set out in Annex I of Council Directive 93/42/EEC; and An undertaking to keep information available for the Secretary of State for a minimum period of five years. These requirements are more or less mirrored in the statement required for active implantable medical devices which are set out in Section 2.2 of Annex 6 to Council Directive 90/385/EEC. Unless the MHRA notifies the manufacturer otherwise, the clinical trial may proceed after the 60 day notification period has elapsed. However, in practice the MHRA generally issues a notice informing the manufacturer that it may proceed at, or within, the 60 days. The MHRA may also attach conditions to a notice, such as a requirement to obtain a favourable opinion from its ethics committee before the trial can proceed. Further, the MHRA may withdraw a notice at any time. After withdrawal no further clinical use may be made of the device. Once a manufacture has received permission to proceed it must conduct the clinical trial in accordance with: Annex X of Council Directive 93/42/EEC for general medical devices; or Annex 7 of Council Directive 90/385/EEC for active implantable medical devices.

5 Finally, the manufacturer has a duty to notify the MHRA of the end of the clinical trial and to provide justification where a trial is ended prematurely. The procedures for in vitro diagnostic devices differ from those for general medical devices and active implantable medical devices in that clinical trials are not necessary. Instead a performance evaluation is required (regulation 43 of the MD Regulations). Before the manufacturer can register a device for performance evaluation he must: prepare a statement containing the information referred to in Section 2 of Annex VIII of Directive 98/79/EC; ensure that the device conforms with documentation mentioned in Section 2 of Annex VIII of Directive 98/79/EC and that the relevant requirements of Directive 98/79/EC are complied with; and undertake to keep available documentation allowing an understanding of the design, manufacture and performances of the device for 5 years after the performance evaluation. Registration with the MHRA is not required if the device was first placed on the market in another state which is party to an association agreement, and the manufacturer has already registered with the competent authorities of the state. Simon Spink & Ralph Cox Fasken Martineau LLP 30 January 2014 This questionnaire is Fasken Martineau s contribution to BioLegis survey of medical devices regulation in 15 European countries, including Israel and Turkey. Biolegis is a network of leading independent European law firms with strong expertise in life sciences, including biotechnology, pharmaceuticals, medical devices and related fields of law. For more information, visit