Product release in the MD industry — A regulatory act, not an administrative formality
Releasing a batch of MDs means affixing a formal and traceable decision that engages the manufacturer's responsibility, opens the way to market placement and determines the response in the event of a recall. Yet, in many organizations, the release process remains unclear: roles overlap between QA, production and RA, the batch file is not standardized, and the traceability required by ISO 13485 §8.2 and MDR 2017/745 is incomplete. This virtual classroom day brings together the three functions concerned to build a robust, documented and auditable release process.
Audience Quality Assurance (QA) teams, production managers and technicians, regulatory affairs (RA) officers involved in the preparation, review or decision to release finished products in a medical device manufacturing company.
Learning objectives
- ▸ Identify the ISO 13485 §8.2.4 and MDR 2017/745 Article 10.8 requirements applicable to the release of finished products and associated traceability.
- ▸ Describe the roles and responsibilities of each function (production, QA, RA, PRRC) in the release process, and formalize delegations of authority.
- ▸ Build the content of an auditable Device History Record (DHR): mandatory records, completeness criteria, traceability chain.
- ▸ Apply release criteria: acceptance, quarantine, refusal of release — and document each decision with the required evidence.
- ▸ Manage complex release situations: release under derogation, partial release, batch recall and link with MDR Article 83 vigilance.
- ▸ Integrate UDI (Unique Device Identification) MDR Article 27 and EUDAMED requirements into the traceability and release process.
- ▸ Prepare the release process for an ISO 13485 certification audit: expected evidence, auditor control points.
Expected outcomes
- ✓ ISOFACADEMY-type release checklist adapted to the participant's context.
- ✓ Commented and ready-to-use DHR (Device History Record) template.
- ✓ Mapping of release process responsibilities (production / QA / RA / PRRC) directly reusable.
Accessibility & entry conditions
Access lead time
Registration up to 10 working days before the start of an open-enrolment session. In-house sessions can be scheduled within 3 to 4 weeks.
Prerequisites
No formal prerequisites. Suggested level: current practice of a QA, production or RA function in an industrial MD organization. Basic knowledge of the ISO 13485 standard is a plus but not mandatory.
Disability access
Any disability situation can be accommodated. Contact our officer before registration to explore possible adjustments (equipment, materials, pacing). Contact our officer →
Funding
- ·OPCO (all sectors)
- ·Skills development plan
- ·CPF (subject to the course being listed)
- ·Company self-funding
Detailed programme
A phone interview or positioning questionnaire is sent ahead of the session to calibrate the level, identify expectations and tailor the case studies to participants' real situations.
- 01
Regulatory and normative framework of MD product release (1h)
- ·ISO 13485 §8.2.4: control of released products — requirements, records, decision authorities
- ·ISO 13485 §7.5.1: control of production and link with release — acceptance conditions, defined criteria
- ·MDR 2017/745 Article 10.8: retention of records, minimum duration, manufacturer obligations
- ·MDR 2017/745 Article 10.9 and role of the PRRC (Person Responsible for Regulatory Compliance) in release
- ·Most frequent observations of notified bodies on the release process during certification audits
- ·Entry quiz on definitions and regulatory requirements
- 02
Roles, responsibilities and delegations in the release process (1h)
- ·Who decides on release? Mapping of functions: production (verification of steps), QA (documentary review and decision), RA (regulatory compliance), PRRC (monitoring regulatory compliance)
- ·Formalizing delegations of authority: release authorization, alternates, documented delegations
- ·Risk situations: schedule pressure on production, absence of the designated releaser, release outside standard hours
- ·Articulation with §6.2 ISO 13485: qualification of the releaser as a prerequisite
- ·Responsibility mapping exercise on a fictional MD organization chart
- 03
Device History Record (DHR): content, structure, completeness (1h30)
- ·Definition and obligations of the DHR according to ISO 13485 §7.5.1.1 and MDR 2017/745
- ·Expected content of a complete DHR: batch identification, raw materials and components, production records, in-process and final controls, release status, destination (UDI/EUDAMED)
- ·Distinction DHR (records of a batch) vs DMR (Device Master Record, product specifications) — articulation between the two
- ·Upstream and downstream traceability: finding a defective component in all batches, identifying all products delivered to a customer
- ·Record retention period: MDR and ISO 13485 rules, specific cases of implantable MDs
- ·ISOFACADEMY-type DHR template provided and commented during the session
- 04
Release criteria and decisions: accept, block, derogate (1h)
- ·Define clear release criteria: product specifications, control results, documentary compliance
- ·Possible statuses of a batch: compliant released, non-compliant blocked, release under derogation
- ·Release under derogation: when is it acceptable, how to document it, what regulatory limits
- ·Refusal of release: procedure, records, link with the NC/CAPA process (§8.3 ISO 13485)
- ·Decision exercise on 3 release cases (compliant batch, batch with minor anomaly, batch with critical deviation)
- 05
UDI, EUDAMED traceability and post-release obligations (1h)
- ·UDI (Unique Device Identification) MDR Article 27: structure, allocation, affixing on the label and the MD
- ·EUDAMED: registration of released MDs, reporting obligations, statuses in the database
- ·Traceability throughout the distribution chain: obligations of the manufacturer, importer, distributor
- ·Link between post-release traceability and vigilance: quickly finding the batches concerned in the event of a report under MDR Article 87
- ·Link between the release process and FSCA (Field Safety Corrective Action) MDR Article 83: triggering a proportionate and documented recall
- ·ISOFACADEMY UDI/EUDAMED release checklist
- 06
Prepare the release process for an ISO 13485 audit (1h)
- ·What an auditor checks as a priority on the release process: the 6 key pieces of required evidence
- ·Recommended documentary organization: release procedure, DHR review instructions, release register, signed delegations
- ·ISOFACADEMY field feedback: recurring observations of notified bodies on the release process
- ·ISO 13485 §8.2.4 release process audit checklist provided to each participant
- ·Open questions and answers and summary of the day
Assessment of learning
Assessment methods
Oral verification points after each module · collective corrections during decision exercises (Module 4) · final QCM of 15 questions (regulatory requirements, responsibilities, DHR content, decision criteria — pass threshold: 60%) · Individual deliverable: release checklist personalized to the participant's context + start of a responsibility mapping of their organization. Training certificate issued subject to full participation in the day. This certificate does not constitute an RNCP/RS certification and does not amount to ISO 13485 certification of the company.
Certificate
A certificate of completion is issued to each participant, detailing the objectives, duration, learning assessed and the result of the final assessment. The document can be kept in a skills record.
Satisfaction and results
Satisfaction rate: Being measured
First learner survey campaign under way — data published once the statistical threshold is reached.
Training team
Training delivered by the ISOFAC ACADEMY teaching team, made up of consultants specialised in medical devices, quality and regulatory affairs. Depending on the module, the session is led by a specialist with hands-on operational expertise in MDR compliance, ISO 13485 quality management systems, ISO 14971 risk management, clinical evaluation, technical documentation, regulatory audits and CE marking strategy.
Our trainers support manufacturers, distributors, importers, authorised representatives and other economic operators on a daily basis in bringing their medical devices into compliance. See the team's profiles →
Technical resources
In-person
Room equipped at the client site or in a partner centre (Montpellier, Lyon, Paris). Video projector, flipchart, printed materials.
Remote
Zoom (corporate) platform for the virtual classroom. Materials provided in PDF + access to additional resources for 12 months after the session.
Learner equipment
A connected computer with camera and microphone for remote sessions. No software to install.
Post-course follow-up
Advice line
Hotline included for 30 days after the session for operational questions arising back on the job. Reply within 48 working hours.
Follow-up review
3-month review sent to the sponsor for in-house courses: feedback on the skills put into practice and any residual points.
Open-enrolment price (excl. VAT)
790 €
EU VAT applicable depending on the buyer's status.
In-house price
On request, depending on headcount and location.
Funding
- ·OPCO (all sectors)
- ·Skills development plan
- ·CPF (subject to the course being listed)
- ·Company self-funding
Personalised quote and OPCO funding application prepared within 48 hours.
Would you like to attend this course?
Tell us your preferred format (open-enrolment, in-house or virtual classroom), the number of participants and your schedule. We will get back to you within 48 hours with the next available dates and a firm quote.