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Further clarification on the MHRA's position regarding regulation for antiseptic/disinfectant wipes and swabs - added 28 Sept 2009
Following the publication of information on regulation for alcohol-only wipes as medical devices in July 2008, further information has been published on the borderlines pages to clarify any mis-interpretation of the regulation. 
› Borderline with medicines

New Guidance Document: Guidance note 20 – Borderlines with medical devices - added 18 Sept 2009
This document provides guidance on the ‘borderline’ between medical devices and other regulatory regimes such as cosmetics, personal protective equipment, biocides etc and provides some examples of products that are or are not medical devices. Note that this guidance does not include the borderline with medicinal products or the borderline with in vitro diagnostic medical devices.
› Medical Device Directive / Other borderlines

Two interpretative documents of the Commission's services have been published at the Commission's website under ‘Interpretative Documents’.
The documents regard:
›  the relation between Directive 93/42/EEC and Directive 89/686/EEC regarding PPE
›  the relation between Directives 90/385/EEC & 93/42/EEC and Directive 2006/42/EC on machinery

The Commission has issued guidance on the transition arrangements for Directive 2007/47/EC - added 11 June 2009
Directive 2007/47/EC was published in the Official Journal of 21 September 2007 and entered into force on the 11 October 2007.
› Implementation of Directive 2007/47/EC amending Directives 90/385/EEC, 93/42/EEC and 98/8/EC (226Kb)

Guidance on the humanitarian provision for medical devices - added 29 May 2009
The humanitarian provisions in the Medical Devices Regulations are intended to allow supply of non-CE marked devices in exceptional circumstances when it is in the interests of public health. Applications are usually considered on a named patient basis but in the event of major disruption to normal procedures such as might occur during a flu pandemic arrangements are in place to deal with applications where shortages of supply of CE marked devices (syringes etc) needed to control the outbreak occur. For information about this please contact John Farquharson on 020 7084 3211. Contingency plans exist for continuity of service to be maintained even if key personnel are unavailable.

Agents / solutions for the transport, nutrition and storage of organs intended for transplantation - added 22 May 2009
Historically solutions for the transport, nutrition and storage of organs for transplantation were not regarded as medical devices in the UK. MEDDEV 2.1/3 (2001 version) (external link) shows that although regulation as medicinal products was considered to be the most appropriate regulatory route at the time the guidance was drafted, many EU Member States do not regulate these products as medicines, as was the case in the UK.

In 2008 the Medical Device Expert Group’s classification and borderline working group came to a consensus determination on the regulation of IVF media and following on from this, extended discussions to the regulation of solutions for the storage and preservation of organs for transplant. In December 2008 the group agreed that these products would be considered as medical devices by analogy of the previous decision on IVF media and this consensus decision was published in the ‘Manual on borderline and classification in the Community Regulatory framework for medical devices’, a copy of which may be obtained from the European Commission’s website at: http://ec.europa.eu/enterprise/medical_devices/borderline_classification_en.htm (external link)

In essence this consensus agreement indicates that in general agents for transport, nutrition and storage of organs intended for transplantation can be considered to be medical devices.

MHRA will therefore accept the CE marking of these products as medical devices in future.

Manufacturers will be given time to comply with the requirements of the medical device regulations for any products they may have which meet the criteria stated in the manual of decisions. Until 31 May 2010, manufacturers may continue to place their products in the market without the CE Mark on the basis that they will be going through the CE marking process. Manufacturers should contact their Notified Body with regard to CE marking the relevant products as soon as possible. After 31 May 2010 all such products placed on the market in the UK should be CE marked under the medical device regulations.

Note that MEDDEV 2.1/3 (external link) is currently under revision and the section referring to these products will be removed in the updated version.

Medical Device Regulations 2002: Regulations 19 and 44 Registration of Persons Placing General Medical Devices and/or In vitro Diagnostic Medical Devices on the Market
The MHRA are currently writing to all UK manufacturers and authorised representatives that are registered with the Agency for placing medical devices and IVDs on the EU market.

The purpose of this letter is to inform registered companies that the MHRA will no longer be able to treat information provided for registration purposes as confidential and it may be released to the public from 21 March 2010.

The MHRA need to ensure that the information released from March 2010 is current and we are therefore requesting that registrants confirm that they wish to remain on the register and that their current details are correct or require updating.

If you have received this letter please complete one of the following actions as necessary;

1. If you need to remain registered with the MHRA and your details have not changed please send an email to angela.bartley@mhra.gsi.gov.uk to confirm this quoting your registration number. There is no £70 fee required in this case.
2. If you need to remain registered with the MHRA and your details require updating (i.e. there has been a change in company name or address or the device categories that you are placing on the market) please complete a new RG2 or RG3 form with your amended details and submit this to the address at the bottom of the first page of the form with the £70 registration fee.
3. If you no longer place medical devices or IVDs on the market and therefore no longer need to be registered with MHRA please send an e-mail to angela.bartley@mhra.gsi.gov.uk to confirm this quoting your registration number. There is no £70 fee required in this case.

If you do not respond to this letter by 31 May 2009 your registration will be archived and you will no longer be registered and therefore will not be complying with the legal requirements.

Please also note that if your letter is returned to the MHRA undelivered your registration will automatically be archived and you will no longer be registered. Therefore, if your details have changed since your initial registration you must get in contact with the MHRA to prevent this from happening.

Contact Angela Bartley on 020 7084 3149, e-mail: angela.bartley@mhra.gsi.gov.uk or Chantelle Williams on 020 7084 3101.

Guidance concerning the availability of medical devices during an influenza pandemic
The MHRA is conducting a consultation on its proposals to deal with a pandemic flu outbreak which in Part IV asks for suggestions regarding specific issues to be dealt with in the guidance being developed on medical device supply arrangements. To contribute to the consultation please see the following guidance:
› MLX 355: Proposals for changes to legislation and working procedures during an influenza pandemic

Responses should arrive no later than Friday 20 March.

First Aid kits
New Guidance is available on First Aid Kits. We have produced this after a request from the Surgical Dressing Manufacturers Association.

› First aid kit guidance document (109Kb)

Medicated and alcohol based wipes and swabs
Medicated swabs/ wipes intended for a medical purpose on humans (for example pre-injection swabs, wound cleansers or for use in a first aid kit) have historically been regulated as medicinal products. Some contain either antiseptics such as chlorhexidine, cetrimide or iodine, but others are alcohol based with no other active ingredient.

MHRA has undertaken a comprehensive review of these types of products in the light of a number of queries regarding their regulatory status and differing views on the appropriate regulatory route within the EU. As a result of this review, MHRA has determined that wipes / swabs containing antiseptics / antimicrobials such as chlorhexidine, iodine, cetrimide and similar will remain as medicinal products and therefore will continue to require a Marketing Authorisation.

Alcohol wipes (i.e. those containing alcohols and water but no other ingredients), however, have a non-specific action. MHRA has determined that there is no reason why such alcohol wipes might not be regulated as medical devices.

As a result of this determination, MHRA will accept the placing on the market of alcohol based swabs / wipes as medical devices. Such products will therefore require to be CE marked under the Medical Device Regulations. Products placed on the market specifically for use ONLY on unbroken skin would be likely to be considered as Class I devices, whilst those for use on injured / broken skin would be likely to be regarded as Class IIa devices.

It should be noted, however, that the position that MHRA has adopted with respect to the regulation of Alcohol wipes may be revised in the event of a European Consensus being reached on the regulation of these products.

Regulation of media used in the IVF process
The issue of the regulation of media used in the IVF process has been a matter of discussion at a European Level for a substantial period of time. The Medical Device Expert Group’s classification and borderline working group came to a determination on the regulation of such products at the last meeting, held in May 2008. The consensus decision on these products has recently been published in the ‘Manual on borderline and classification in the Community Regulatory framework for medical devices’, a copy of which may be obtained from the European Commission’s website
› Manual on borderline and classification in the Community Regulatory framework for medical devices (external link)

In essence this consensus agreement indicates that in general IVF media will be considered as Class III medical devices under classification rule 13 as stated in Annex IX of the Medical Device Directive 93/42/EEC (external link).

MHRA will therefore accept the CE marking of these products as medical devices in future.

Manufacturers will be given time to comply with the requirements of the Medical device regulations for any products they may have which meet the criteria stated in the manual of decisions. During this time manufacturers may continue to place their products in the market without the CE Mark for a reasonable period whilst they are going through the CE marking process. They should, however, contact their Notified Body with regard to CE marking the relevant products as soon as possible.

Public consultation on amendment to the Medical Devices Regulations 2002
The Agency begins a public consultation to amend the Medical Devices Regulations 2002.

The Agency begins a public consultation to transpose the Medical Devices Directive 2007/47/EC which amends the medical devices and the active implantable medical devices Directives into UK law.

The closing date for comment is 15 August 2008

› Public consultation - Medical Devices Regulations 2008 - Transposing (64Kb)
› Directive 2007/47/EC of the European Parliament and of the Council - 5 September 2007 (193Kb)
› The Medical Devices (Amendment) Regulations 2008: Statutory Instrument 2007 No. Consumer Protection (29Kb)
› Impact assessment of Directive 2007/47/EC, Council Directive 90/385/EEC, Council Directive 93/42/EEC, Directive 98/8/EC (664Kb)

The European Commission launch a public consultation on proposals to recast the medical devices Directives
The European Commission have posted a questionnaire on their website seeking views on proposals to further revise the medical devices Directives.

› Recast of the Medical Devices Directives public consultation (external link)

MHRA will be putting together a formal UK response in liaison with representatives of stakeholder organisations but any comments are encouraged either to us at the Agency to feed into our response, direct to the Commission or through your trade bodies. The deadline for responses is 2 July after which the Commission will come up with more detailed proposals we believe towards the end of the year.

EU Competent Authority Meeting for Medical Devices in Brdo, 25-26 February 2008
The above meeting has taken place and a press release (external link) issued.

Making medical device vigilance more effective - Important forthcoming changes in EU medical device vigilance guidance
Post-market surveillance and vigilance reporting are key areas for manufacturers and EU authorised representatives to get right. Getting them wrong can lead to reduced safety for users and also cost companies dearly in lost reputation and market share.

The new EU MEDDEV 2.12-1 Rev 5 ‘Guidelines on a medical devices vigilance system’ (external link), which provides best practice guidance on the interpretation of the vigilance requirements in the EU medical devices directives, is a significant revision from the previous version. Any manufacturer selling on the European market should make sure that their vigilance systems are updated to meet the revised guidance by 01 January 2008. 

MHRA have published a short article summarising the: development of the guidance; key areas that have changed significantly or that have been introduced for the first time; and plans for new MHRA guidance which will detail how the new EU vigilance guidance is being implemented by the MHRA in the UK and best practice vigilance guidance for manufacturers selling onto the UK market.

MHRA statement on talc preparations for Pleurodesis
MHRA is of the opinion that talc preparations for pleurodesis are medicinal products.  They promote an inflammatory reaction in the local tissues through a metabolic / immunological response after exposure to the talc. MHRA therefore considers that these are not medical devices and intends to treat these products as medicines with effect from 01 January 2008

Consequently, talc preparations for pleurodesis should be licensed as medicinal products for use in the UK and manufacturers of these preparations are invited to submit appropriate manufacturing authorisation applications. Further information concerning the regulatory requirements for licence applications is available from the MHRA website (1).

Given the current absence of licensed talc preparations for pleurodesis these products will be required to be prescribed by healthcare professionals as unlicensed medicines for the special clinical needs of individual patients on the direct personal responsibility of the prescriber.

Further information concerning the regulatory requirements for unlicensed medicines are provided in the MHRA Guidance Note No 14, “The Supply of Unlicensed Relevant Medicinal Products for Individual Patients”, which is available from the MHRA website (2).

Importers of any medicine that is unlicensed in the UK must notify the MHRA in accordance with The Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005/2789. For further information, please see also Guidance Note 14.

Notifications for importation of unlicensed medicines received by the MHRA will be assessed in the normal manner and objections may be raised where there are prohibitive safety or quality concerns, or in the case of non-objections to import, advice issued where users need to be aware of safety or quality issues.

Users should consult their suppliers to ensure continuity of supply following these changes.

Users should be aware that published literature (3) indicates that there may be an increased incidence of adverse reactions, including delayed adult respiratory distress syndrome, linked with the use of small particle size talc preparations. It is therefore important that all adverse events, whether real or suspected, associated with the use of these products are reported to MHRA in order to help build up a safety profile.

Adverse reactions should be reported to MHRA via the following link:
› Healthcare professional Yellow Card online form

Recipients are asked to bring this information to the attention of professionals with an interest in respiratory medicine by copy of this letter.

References
MHRA Web Pages
1. Requirements for Marketing Authorisations

2. MHRA Guidance Note No 14

3. Recent Published Literature

3.1. J P Collier et al, “Safety of pleurodesis with talc poudrage in malignant pleural effusion: a prospective cohort study”, The Lancet, 369, pg 1535 -1539, (2007).

3.2. M Noppen, “Who’s (still) afraid of talc?”, European Respiratory Journal, 29, pg 619 - 621, (2007).

Medical Devices Directive revision
The European Commission have published the final text of Directive 2007/47/EC which amends the Medical Devices and Active Implantable Medical Devices Directives. This follows a thorough going review of the existing provisions which was concluded with agreement of the changes in the Council of Ministers on 25 July 2007. Member States now have until 21 December 2008 to transpose the new Directive into national law. Following which there is a transition period for manufacturers to come into compliance by 21 March 2010.
› Amended version of the Directive (189Kb).

Foot and Mouth: Impact on medical devices containing animal material
The MHRA has ascertained, following detailed discussions with DEFRA (Department for Environment, Food and Rural Affairs), that the impact of the restrictions imposed to deal with the foot and mouth outbreak will have a minimal impact on the supply of medical devices containing animal material from cows, sheep, pigs, goats and other biungulates.

1. Devices containing animal material from other animal types are not affected.

2. Devices containing bovine, ovine, porcine, caprine or other biungulate animal materials that are sourced from overseas can be imported and moved about the country without any restriction.

3. Similarly there are no new or additional restrictions on the movement and placing on the UK market of products containing UK sourced animal materials of this type.  Live animals from outside the controlled area can now be slaughtered and provide the source material for devices.

4. The only ban that is currently in place relates to the export of devices containing animal material of these types sourced from within the UK after 15 July which are not subject to other exemptions detailed in the Import and Export Restrictions (Foot and Mouth) Regulations 2007 (external link).

5. These exemptions though include in vitro diagnostic reagents and other products containing pre-processed animal material that has been imported from overseas (as long as it has been transported, stored and processed separately from other affected products). Furthermore devices containing UK sourced animal material from the specified groups which has been subjected to heat treatment in a hermetically sealed container with a Fo value of more than 3,00 or centre temperature raised to at least 70°C, blood and blood products and finished composite products containing UK sourced animal material that has been certified by DEFRA inspectors can also be exported. 

6. MHRA is pursuing the possibility of seeking an exemption to allow the export to other EC member states of all devices made in the UK containing animal material as long of course that they are legitimately CE marked in accordance with the requirements of the medical devices directives. However whether this will be necessary depends on how long the ban stays in place in light of the growing confidence in containment measures.

7. The risk of lifting the ban on exports of medical devices containing animal material in terms of controlling the spread of Foot and Mouth will be assessed by the Standing Committee on the Food Chain and Animal Health in considering whether an exemption can be granted.  It should though also be noted that the clinical implications for humans are negligible. There has only been one recorded case of FMD in a human being in the UK which was back in 1966. The general effect was similar to influenza with some blisters and it is a short-lived self limiting disease. The Food Standards Agency have also advised that the disease in animals has no implications for the human food chain.

If you have any further queries please contact David Batten on 020 7084 3254 (david.batten@mhra.gsi.gov.uk), or the DEFRA central exports contact point in Lincoln on 01522 563132 (lincoln.iahsdu@animalhealth.gsi.gov.uk). 

EU Competent Authority Meeting for Medical Devices in Lisbon, 5-6 July 2007
The above meeting has taken place and a press release (77Kb) issued.

EU Competent Authority Meeting for Medical Devices in Bonn, 25-27 February 2007
The above meeting has taken place and a press release (external link) issued.

Other Amendments to the Medical Devices Regulations 2002

Short note for the Medical Devices (Amendment) Regulations 2007
The Medical Devices (Amendment) Regulations 2007 which transpose Directive 2005/50/EC is available from Related Information.

Short Note for other amendments made by the Medical Devices (Amendment) Regulations 2007
The Medical Devices (Amendment) Regulations 2007 apart from implementing Directive 2005/50/EC makes other amendments in light of the operation of enforcing the Medical Devices Regulations 2002.

Firstly, the regulations amend Regulation 61 in respect of the time limit to commence proceedings for those offences which are summary under the Consumer Protection Act 1987. When the Regulations had been consolidated through the 2002 Regulations, we included an extension so that we could take action within 12 months from the time the offence has been committed. We have since discovered, this too has caused us difficulties in terms of enforcement of certain breaches of the Regulations. So we have amended Regulations to provide a limit of 3 years from the date of the offence or one year from the date if discovery of the offence whichever is the earlier. This will ensure a more effective enforcement regime.

Secondly, the Regulations have amended Regulation 3 which excludes devices incorporating human blood, blood products, plasma or blood cells of human origin as well as transplants or tissue cells of human origin, or products incorporating or derived from tissues or cells of human origin currently from Directive 93/42/EEC. This is in order to clarify that In-vitro diagnostic medical devices as defined under Directive 98/79/EC are not included within the scope of the current exclusion.
› Transposition Note for Commission Directive 2005/50/EC of 11 August 2005 on the reclassification of hip, knee and shoulder joint replacements in the framework of Council Directive 93/42/EEC concerning medical devices
› Full Regulatory Impact Assessment (107Kb)
› Summary of responses to the public consultation concerning the transposition of the reclassification directive 2005/50/ec for hip, knee, and joint shoulder replacements commenced on 31st August 2006 to 30th November 2006 (17Kb)

Proposed increase to Medical Devices Fees
The MHRA has now completed its consultation regarding a proposed increase in the fees that it charges to the medical devices industry and notified bodies for some of its medical device regulatory activities. This followed a rigorous costing exercise with increases being targeted to reflect actual costs. Information on the proposed fee increases is available in the public consultation document RCX/004/002/036.

Phthalates/DEHP in PVC medical devices
We have published guidance on how the Medical Devices Directive applies to devices containing phthalates. Any questions on regulatory aspects should be directed to:

David Batten
European Regulatory Affairs
Medicines and Healthcare products Regulatory Agency
E-mail: david.batten@mhra.gsi.gov.uk
Tel: 020 7084 3254

Or on scientific/technical matters
Sandra Costigan
Biosciences & implants
Medicines and Healthcare products Regulatory Agency
E-mail: sandra.costigan@mhra.gsi.gov.uk
Tel: 020 7084 3281

EU Competent Authority Meeting for Medical Devices in Tampere, 6-7 July 2006
The above meeting has taken place and a press release (44Kb) issued.

Introduction of the General Product Safety Regulations 2005
The General Product Safety Regulations 2005 has come into force on 1 October 2005. It transposes into UK law the revised General Product Safety Directive 2001/95/EC. The previous Directive 92/59/EEC and 1994 Regulations have been repealed. Under the new Regulations, MHRA is an enforcement authority in respect of medical devices that are consumer products (i.e.  either sold over the counter or in someway migrate to the consumer market).

As an enforcement authority, MHRA will be able to take enforcement action against those who distribute such products, where there is the possibility that they maybe considered to be dangerous or alternatively, serve a recall notice, requiring an individual to organise the return of goods supplied to consumers, where such goods might present a risk to consumers.

The link to the regulations is obtainable on the right hand side under related information.

Medical Devices (Amendment) Regulations 2005
On the 1 October 2005 the General Product Safety Regulations 2005(SI 1803) was transposed into UK law the General product Safety Directive 2001/95/EC. The Directive revises the original Directive 92/59/EEC as transposed by the 1994 Regulations.

The transposition of the Directive did not ultimately affect the position of MHRA, as an enforcement authority under the Medical Devices Regulations but did cause jurisdictional problems for Trading Standards Officers in terms of defining the types of devices that they had jurisdiction over. Therefore, it was necessary to introduce the Medical devices (Amendment) Regulations 2005 to ensure that Trading Standards Officers’ powers to enforce the Regulations is retained.

Medical Devices Utilising Tissues of Animal Origin on the Market (updated  March 2007)
The Medical Devices (Amendment) Regulations 2003 (S.I. No 1697) implement into UK law Commission Directive 2003/32/EC on Medical Devices Manufactured Utilising tissues of Animal Origin and amended the Medical Devices Regulations 2002. The majority of regulations came into force on 1st September 2003. However, the relevant provision as it applies to medical devices utilising tissues of animal origin came into effect on 1st April 2004 by virtue of Regulation 19A. The amendment was designed to give effect to the Commission Directive in order to improve existing measures to reduce the possible risk of patient or user infection with Transmissible Spongiform Encephalopathies (TSE) from medical devices which incorporate tissues or their derivatives from bovine, ovine and caprine species, as well as deer, elk, mink and cat.  The Commission Directive covers medical devices within the framework of the Medical Devices Directive 93/42/EEC and applies to new devices first placed onto the market as well as requiring devices that were already on the market to be subject to enhanced risk assessment and risk management scheme.

Under the Commission Directive, manufacturers are required to have their conformity assessment process verified by the Notified Body. The effect of the Directive is that it better defines the risk assessment that the manufacturer has to undertake and the level of scrutiny the Notified Body has to undertake. During this process, the Notified Body concerned will have to consult with their own Competent Authority who also liaises with the other Member States, for review, before the Notified Body issues the EC Certificate of Conformity.  The increased scrutiny of the Notified Body together with consultation with other Competent Authorities will provide a more rigorous conformity assessment procedure for such products. The required certificates for manufacturers of existing products on the market should have been issued by 1 May 2005 if they wish to maintain these products on the market.

Any certificates for 'new' products issued after 1st April 2004 must be processed through the new system described above (i.e. via the required NB and Member State consultation process)."