https://www.bspartnership.co.uk/home daily 1.0 2025-02-04 https://images.squarespace-cdn.com/content/v1/5de9770843140d198883a71b/1575582447029-5NTMIDEM9OX31FK60OS0/image-asset.jpeg Home - “ BS Partnership has helped us develop and continually improve our fulfilment of the standard throughout software and staff changes, and relocation. We anticipate that we will still be using them in another 10 years time! — Cambio Ltd https://images.squarespace-cdn.com/content/v1/5de9770843140d198883a71b/1577713309480-WKE1G0UN843ZO9QYHVB5/image-asset.jpeg Home - What we do Founded in Cardiff, UK, in 1992 by Julian Baines MBE and led by Managing Director Jonathan Phillips since 1997, our company has grown into a leading regulatory compliance consultancy serving customers worldwide, including Canada, China, Denmark, England, France, Germany, India, Scotland, Sweden, the USA, and Wales. We began with ISO 9001 and ISO 13485 consultancy and training, expanding to provide comprehensive support for CE and UKCA compliant quality management systems and technical files. Our services include both on-site and remote audits, guiding clients through the entire certification process. Through our Belfast-based subsidiary, EU-UK Authorised Representative Ltd, we provide essential services under the new EU General Product Safety Regulation (EU) 2023/988 (GPSR). This strategic presence enables us to serve as an authorised representative for companies needing representation in both the EU and UK markets. Our GPSR services include guidance on mandatory accident reporting, product registration systems, recall procedures, and compliance with new requirements for product safety, risk assessment, and traceability systems. We also provide specialised EU Authorised Representative services for medical devices and in vitro diagnostic medical devices under EU MDR 2017/745 and EU IVDR 2017/746, ensuring manufacturers outside the EU can meet their regulatory obligations for these regulated products. Our comprehensive Importer Services division assists businesses in bringing products into both the UK and EU markets, ensuring full compliance with all relevant regulations including GPSR requirements for economic operators across both jurisdictions. If you have any questions about our services or need assistance with regulatory compliance, please don't hesitate to contact us. Best Wishes, Jonathan Phillips https://images.squarespace-cdn.com/content/v1/5de9770843140d198883a71b/1575582390727-BIDUZ896PRX56ZCK9CHM/image-asset.jpeg Home https://images.squarespace-cdn.com/content/v1/5de9770843140d198883a71b/1575743455800-TPZVW6AE4RBS0E8X3VRV/image-asset.jpeg Home https://www.bspartnership.co.uk/consultancy daily 0.75 2025-02-04 https://images.squarespace-cdn.com/content/v1/5de9770843140d198883a71b/1576704282233-LGCELA773LUOARF12EXZ/image-asset.jpeg Services Provided - Consultancy We provide consultancy and training in quality management and regulatory compliance, including: ISO 13485 for medical devices and IVDs - quality systems, technical files, audits, regulatory support MDR and IVDR transitions - technical documentation, quality systems, regulatory requirements GPSR compliance - risk assessments, technical files, product safety systems ISO 9001, ISO 14001, and ISO 45001 - management systems, documentation, implementation support, audits We support product development from concept to market, with comprehensive technical documentation services and both on-site and remote audits for certification readiness. https://images.squarespace-cdn.com/content/v1/5de9770843140d198883a71b/1589461663777-0WM8KPTDT40YOIOVDUWR/image-asset.jpeg Services Provided https://images.squarespace-cdn.com/content/v1/5de9770843140d198883a71b/1589461774519-V3FPCBOHC9VZX0DLLX0T/image-asset.jpeg Services Provided https://images.squarespace-cdn.com/content/v1/5de9770843140d198883a71b/1589461546244-N7SU9S8QDOLNIQ9S553Y/image-asset.jpeg Services Provided https://www.bspartnership.co.uk/blog daily 0.75 2026-01-02 https://www.bspartnership.co.uk/blog/ivdr-class-c-transition-are-you-ready-for-may-26-2026 monthly 0.5 2026-01-02 https://www.bspartnership.co.uk/blog/eu-commission-proposal-to-amend-the-medical-device-and-ivd-regulations monthly 0.5 2025-12-16 https://www.bspartnership.co.uk/blog/the-regulatory-affairs-stocking-filler-3-tasks-to-finish-before-the-year-ends 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https://images.squarespace-cdn.com/content/v1/5de9770843140d198883a71b/1585002680126-FA8PP7IJ04JQBQYVX3AT/image-asset.jpeg Authorised Representative (CE) https://images.squarespace-cdn.com/content/v1/5de9770843140d198883a71b/1608199391594-V2H4LN92GVQL61P9B7EP/image-asset.jpeg Authorised Representative (CE) - Who can be a PRRC? Article 15(1) of the MDR and the IVDR calls for a person possessing the requisite expertise in the field of medical devices, which is defined as qualifications that are demonstrated by either: (a) a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices. or: (b) four years of professional experience in regulatory affairs or in quality management systems relating to medical devices. While formal qualification is easily documented with a diploma or certificate, professional experience in medical device regulatory affairs or in quality management systems (referring to experience gained in the EU) must be demonstrated as well. Qualification based on professional experience must be substantiated with documents such as a work contract, organisation chart, training evidence or internal records such as document releases. https://images.squarespace-cdn.com/content/v1/5de9770843140d198883a71b/1608199232777-251ZICAFZW6DV8DRXPTN/image-asset.jpeg Authorised Representative (CE) - Person Responsible for Regulatory Compliance (PRRC) All manufacturers and EU authorised representatives must have a PRRC. Manufacturers are required to confirm that their EU authorised representative has appointed a person meeting the PRRC qualifications as outlined in Article 15 of the MDR and IVDR. If a company consists of more than one legal manufacturer, each legal manufacturer must appoint its PRRC. MDR and IVDR introduce the new role of the person responsible for regulatory compliance, the PRRC. Manufacturers and authorised representatives are required to appoint a PRRC PRRCs must demonstrate adequate qualifications for this role. Where the organisation is a micro or small business it is possible to outsource the PRRC role to an outside expert. https://www.bspartnership.co.uk/ukca daily 0.75 2020-12-17 https://images.squarespace-cdn.com/content/v1/5de9770843140d198883a71b/1608199483912-SDTCEF5UNAOCLGYYWPL7/image-asset.jpeg UKCA https://images.squarespace-cdn.com/content/v1/5de9770843140d198883a71b/1608203258977-QXB53XI5NNNXYU3LY5J7/image-asset.jpeg UKCA https://www.bspartnership.co.uk/contact-us daily 0.75 2020-12-03 https://www.bspartnership.co.uk/meet-the-team daily 0.75 2024-04-15 https://images.squarespace-cdn.com/content/v1/5de9770843140d198883a71b/1606996231808-3Z8QRGS44ZG1B728EIZ3/0.jpeg Meet the Managing Director https://www.bspartnership.co.uk/our-clients daily 0.75 2020-12-18 https://www.bspartnership.co.uk/euuk-authorised-representative-ltd daily 0.75 2020-12-15 https://www.bspartnership.co.uk/importer-services daily 0.75 2025-02-04 https://www.bspartnership.co.uk/store daily 0.75 2023-03-20