CE-marking of Medical Devices and complete Medical Gas Pipeline Systems (MGPS) Holsterbro Sygehus - Denmark
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1 CE-marking of Medical Devices and complete Medical Gas Pipeline Systems (MGPS) Holsterbro Sygehus - Denmark Johan Arnfelt Marketing & Bus Dev Mngr, Linde Healthcare EMEA
2 Agenda - My background - Why CE-marking? - How to obtain CE-marking? - What shall be CE-marked? - Maintenance, Repair and Changes - CE-marking of Medical Gas Pipeline Systems MGPS - Change from MDD to MDR - Questions as we go! Fußzeile
3 My background - Master of Science, Industrial Economy and Mechanical Engineering - 16 years Business and Product Owner for Medical Devices and Hospital Services - CE-marked 17 medical devices - Now: Central Gas Equipment +related services Linde (AGA) Europe Middle East and Africa - 12 years Swedish and ISO standardization committees - 6 years ISO-expert - Medical Gas Systems + Family, ski, surf, tennis 3 Linde: Living healthcare
4 Why CE-marking? the most wonderful relief and cure of all chronic and nervous diseases, all diseases, disorders, and weaknesses peculiar to men, NO MATTER FROM WHAT CAUSE OR HOW LONG STANDING -Sears Roebuck & Co, product catalogue Linde: Living healthcare
5 Why CE-marking? Standards, Regulations and Laws Patient Safety!! - Defects or disturbances in the function of medical devices Serious risk to patients, staff or 3P - Medical Device Directive (MDD) Safety, Performance and free trade in EU - CE-marking in accordance with MDD is a legal requirement when making medical devices available (sell/lease/lend ) to the EU market since 1998
6 How to obtain CE-marking? - CE-marking = Medical Device Manufacturer claim the product safe by fulfilling all essential requirements in European Medical Device Directive (MDD). - MDD essential requirements (60) outlines safety and performance requirements needed to be sold in EU. - Harmonized product standards (e.g. ISO7396-1) - ISO13485 QMS Production of Medical Devices - ISO14971 Risk Management - Technical File audited by Notified bodies NB (DNV, TÜV, BSI ) CE, Class I, IIa, IIb or III. - NB are authorized by Medical Product Agencies (Sundhetsstyrelsen) - MDD EU-Directive, but also implemented into national laws. E.g. According to Swedish law 17 Den som med uppsåt eller av oaktsamhet släpper ut en medicinteknisk produkt på marknaden eller använder en sådan produkt i Sverige utan att produkten uppfyller de krav och villkor som gäller enligt 5 eller enligt föreskrifter som beslutats av regeringen med stöd av 6 döms till böter eller fängelse i högst ett år. 6 Linde: Living healthcare
7 What products/devices shall be CE-marked? Examples: All types of Medical Gas Regulator A, Part of treatment of e.g. lung diseases B, Active device (since changes energy/property of the gas) Rule 11, class IIb Medical Gas Pipes A, Part of treatment of e.g. lung diseases B, Non invasive device used for channeling or storing a medicine Rule 2, class IIa 7 Linde: Living healthcare
8 Maintenance, Repair and Changes to Medical Devices Maintenance & Repair - Always follow the instructions for use (+intended use) - If you do not follow instruction for use: A, Unclear if the device is fit for its purpose B, The CE-marking of the device is invalid the product is not a medical device C, Manufacturers Product Liabilities invalid D, Product Warranties (typical 2-5 years) are invalid E, Can change to in-house manufactured? - Training needed? - Approved spare parts? - Only authorized technicians (inhouse or external person)? Changes - Can only be permitted by manufacturer - Written instruction including final test - Decided by the manufacturer s Notified Body 8 Linde: Living healthcare
9 CE-marking of Medical Gas Pipeline Systems, MGPS - The MGPS is used for treatment of e.g. lung deceases. Rule 11: class IIb, A Medical Device to be CE-marked by the manufacturer (hospital or installation company) Fully CE-marked MGPS systems - 6 countries in Europe In-house manufacturing - 22 countries - Hospital is the legal manufacturer - Not allowed to be placed on the market (sell/lease/lend to 3P) - Up to national legislation. - Sweden: Same essential requirements from MDD are required, but no formal CE-marking - Swedish authorities are demanding a written Declaration of Conformity from hospitals that MDD and applicable standards (e.g. ISO7396-1) are fulfilled. 9 Linde: Living healthcare
10 Change from MDD to MDR - MDD = Medical Device Directive - MDR = Medical Device Regulation - Most important is that a regulation must be implemented directly in all of EU, no interpretations into national laws. High Lights: - MDR is 4 times longer than MDD - Esthetic and single use devices are included - Stronger reinforcement of rules for clinical evaluations - Stronger reinforcement of post market surveillance - Creation of EUDAMED-database (Device, market, distributor etc) - Introduction of UDI (Unique Device Identifier) - Stricter requirements on Notified Bodies (DNV, TÜV, BSI..) Specific for MGPS - According to MDR no in-house manufacturing if CE-marked exist in the market. - Swedish MPA has asked for a guiding document. 10 Linde: Living healthcare
11 The System that must NEVER fail! At least 3 sources of supply! 11 Linde: Living healthcare
12 QI Services Quality Improvement Services designed to help healthcare facilities managing the demands, laws and regulations related to distribution and use of medical gases.
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