Medical Devices Social Compliance
Social Compliance of surgical tool manufacturing is a focal point for Western buyers after the reports of Child labour and human cost of manufacturing surgical goods. Medical devices is our specialist area of work from many years. Surgical supply chain is one of the most complex supply chain due to over 50 processes of manufacturing involved in the production , with multi vendor structure. Medical device social compliance is a global challenge and require timely adaptations and rigor.
We enable surgical Instrument manufacturing companies to reach social compliance in line with the international requirements to NHS Supplier code of conduct, Modern Slavery Act and Social value Act. Our services include industry specific interventions by providing tools, training, technical expertise, robust system and capacity building to meet social compliance.
Labour standards assurance system- LSAS
Labour standards assurance system is mandatory requirement from Public sector UK specifically for anyone supplying goods and services under public framework agreements to National Health Services. This applies now to OJEU, NHS supply chain, PASA, and NHS Shared Business services contracts. LSAS provides an integrated management system to assure organisation are following labour standards. The system builds on a continuous cycle of monitoring and improvement. LSAS is a progressive system with 4 levels of performance- Foundation ( Level 1), Implementation ( Level 2), Establishment ( Level 3) and Progressive ( Level 4). All four levels require to demonstrate progression in set timeframe as per supplier contract requirement.
NHS Supply Chain describes LSAS as:
“A Labour Standards Assurance System (LSAS) refers to the range of policies, procedures and practices that an organisation employs to identify labour standards abuses, mitigate risks and drive improvement”
This system is not a certificate scheme but provides a performance report against labour standards. LSAS is applicable to any company providing the product categories related to furniture, stationary, stainless steel, fabric and plastics to NHS Supply Chain. The framework revolves around 9 ETI principles, local labour laws and their implementation in the supply chain. The scope of the audit extends to the organisation itself, its contractors and subcontractors.
Global Sustainability UK is pioneer in providing complete LSAS solution to NHS suppliers across the globe from past 8 years. Our solution include:
NHS suppliers are located globally, presenting a complex supply chain. With the Modern Slavery Act 2015, NHS suppliers code of conduct and Social Value Act 2012 , NHS is faced with a challenge of becoming a responsible business. Section 54 of Modern Slavery Act refers to transparency of supply chains and a requirement for a modern slavery statement. It is crucial for NHS to be aware of the risks in supply chain pertinent to social and labour abuse including modern slavery related risks. This require a high level of commitment and collaboration. MSAT is a Free of cost tool accessible to suppliers for assessing their supply chains and identify any risks. MSAT will be an extension for organisations that are already on LSAS and will focus on
- Protecting Human rights in supply chain
- Transparency in supply chain
- Due dilligence
This tool requires review and constant update with any change to supplier, Developments in statement, policy, code of conduct, communication with suppliers, corrective actions, and system implementation.
Our team is well equipped to help businesses to support with MSAT self-assessment tool and reach compliance to the social standards as required by NHS. Our services are mapped to the tool and respond to all questions along with technical information, providing risk assessments, helping with documentation and evidence required , training of staff and delivering internal and supplier audits as per requirements of the new tool. We can help with
- Moderns slavery statement and its publication
- Supply chain mapping
- Identifying and map high risks in supply chain
- Risk prevention strategy and actions
- Establishing policies related to Modern Slavery, Human rights at work and Labour standards
- Technical assistance to collate procedures on delivering Social and Labour standards
- Embed due diligence
- Risk mapping and Actions at operational level
- KPIs to ensure effectiveness
- Detail impact analysis
- Training and collaboration
UK Responsible Person and Europe Authorised Rep ( EU AR)
The UK Responsible Person is a new role created under the Medical Devices Regulation 2019 (UK MDR).
‘Where a device manufacturer is not established in the UK, registration of a product with the MHRA must be undertaken by a ‘UK Responsible Person’ established in the UK and with a UK registered address who will take responsibility for the product in the UK. No labelling changes will be required to reflect the role of this ‘UK Responsible Person’
UK responsible person will act on behalf of non-UK manufacturers to perform specific tasks regarding manufacturers obligations under these regulations. The key tasks and responsibilities of this role will include registering with the MHRA before a device is placed on the UK market. The responsible person also coordinates any requests between manufacturer and MHRA and immediately report any complaints to the manufacture. A full list of the responsibilities are set out in Part II (r. 7A), Part III (r. 21A) and Part IV (r. 33A) and in new Parts VIII and IX in regulation 77 (for medical devices) and regulation 146 (for in-vitro diagnostic devices (IVDs)) of the UK MDR 2002 (as amended by the UK MDR 2019).
Global Sustainability UK has been supporting business from many years by providing services as authorised Representative for UK and Europe including getting free sale certificates. Under new Medical Devices regulation in Europe, new responsibilities are added to the role of EU AR that includes being legally responsible to retain all technical documents and certificates regarding devices. AR should have access to any changes in the medical devices, maintenance records, and post market clinical follow up. It is also required that EU AR information should be robust and including in product communication materials and labels including Inserts, IFU’s and user manuals.
As your authorised Representative in UK and Europe, we will provide following services.
We will represent your business in UK and Europe, maintain your technical file as per MDR requirements, managing your electronic data submissions, liaise with competent authority on your behalf for any submissions or queries, getting you approved for CE mark by a competent authority, update all parties for any serious incidents, keep you updated for any changes in the regulations.
FREE SALE CERTIFICATE and Apostille
A Certificate of Free Sale (CFS) is an attestation that your product complies with the relevant legislation and may be freely sold in the UK or Europe, and can be exported to countries which may not have their own regulatory regimes.
Global Sustainability UK can arrange Free Sale Certificate for your devices if you have an authorised representative in UK and your device is CE Certified. If required we can also apostille your device with ministry of foreign affairs. All European CFS will be issues as per European Medical Device Regulations: Directive 93/42/EEC and the In-Vitro Diagnostic Directive 98/79/EC.
To issue a CFS for UK or Europe, we would require full details of the device(s), including but not limited to its Manufacturer’s information. Device name, Classification, Intended use, full description, Declaration of Conformity, QMS certificate, CE certificate, Lead contact for manufacture. In case your device is registered with some other company, we can support you transfer your AR agreement with us.
Social Compliance and Code of Conduct
Corporate Social Responsibility (CSR) and compliance to Social and Ethical code of conduct are considered as performance conduct of an organisation against Social standards related to human rights, labour regulation and working conditions. Acknowledging the complexity caused by legislative variations and industrial norms, we actively work with industrial partners and clients to enable organisations to implement social standards and meet compliance. Our services are available for various sectors, including textile, surgical, printing, food, minerals and aluminium. We cater for brand code of conduct, company’s own code of conduct and main compliance schemes including ISO26001, SMETA 4 pillar, SA8000, LSAS, RJC, ASI , OCS, RBA,PSCI , WRAP and BSCI.
We believe in enabling our clients all through their journey to deliver on social compliance be it their brand requirement, CSR initiative or Audit. Our services include;
- Gap analysis and improvement program
- Capacity building, training and coaching
- Systematic framework of continuous evaluation and improvement
- Performance measurement through assessments and audits