MHRA follow-up questionnaire on Business Engagement Assessment on EU Commission Regulation 207/2012 on electronic labelling of medical devices
As you may be aware MHRA circulated a questionnaire on the working draft of the above EU Commission Regulation in the first quarter of 2011 to which a number of helpful responses were received. The Regulation came into force on 1 March 2013 and MHRA has published guidance on its website[1].
The attached questionnaire is designed to collect further information from devices manufacturers to better understand and gauge the likely economic and financial impact of this new policy.It should be considered in conjunction with the draft Business Engagement Assessment on the e-labelling Regulation which seeks to quantify and consult with industry on the impacts of regulation.
Businesses are asked to return the completed questionnaire along with any comments on the Business Engagement Assessment to by2 August 2013.
Firm and sector specific questions
1a )Is any or all of your products in scope of the EU Commission Regulation207/2012 on electronic labelling of medical devices?
Yes / No
1 b )What size is your business? Please tick appropriate:
□ micro business (i.e. <10 employees)
□ small business (i.e. between 10 and 49 employees)
□ medium-size business (i.e. between 50 and 249 employees)
□ large business (i.e. >250 employees)
1c )For the devices in scope of the Regulation, have you started or will you be starting to supply the Instructions For Use (IFU) inelectronic form?
Yes / No
1 d )If you have answered question 1 c ) with “No” can you please explain why you will not be starting to supply your IFUs in electronic form?
2 a )Can you estimate the total number of UK based companies that are in scope of the regulation?
OR
2 b )Can you estimate the proportion of firms that are affected by the regulation out of all UK based companies in the Medical Device Manufacturing Sector?
2 c )Can you estimate the proportion of micro and small size companies (firm-sizes as defined in question 1 b ) in the UK based medical devices manufacturing sector that are affected by the regulation?
Benefits
3 a )We believe that the benefits of this Regulation will be in the form of saved printing, paper and logistics costs by substituting paper-based with electronic IFUs.
If you have answered question 1 c ) with “Yes”, can you please estimate the total annual cost saving to your company of not supplying paper manuals? Can you please break down your savings by annual:
Printing costs:
Paper costs:
Logistics costs:
3 b )Have you identified any other benefits? Please provide a clear description of these benefits and quantify them where possible.
Costs
4 a )We have identified some possible costs that may arise from moving to provide electronic instead of paper-based IFUs.
Can you please tell us:
- whether they apply to your company
- if they do, comment on whether they are transitional or ongoing
- give an estimate of them
- website creation/adaptation and maintenance costs due to the provision of IFUs online
apply / do not applytransitional / ongoingXX£ p/a - familiarisation costs with the regulation text
apply / do not applytransitional / ongoingXX£ p/a - costs of providing individually requested paper-based IFUs
apply / do not applytransitional / ongoingXX£ p/a - increases in Notified Body fees
apply / do not applytransitional / ongoingXX£ p/a
4 b )Have you identified any other costs? Please provide a clear description of these costs and quantify them where possible.
4 c )The government is concerned about the regulatory burden on small and micro businesses.
Have you identified any additional or disproportionate burden from the Regulation on small or micro businesses? Please provide a clear description of these burdens and quantify them where possible.
Comments on the Business Engagement Assessment
5 a )Please include any comments you have on our Engagement Assessment in the box below.
[1]