EU MDR Common Specifications Are Not Common

by Diane Kulisek | Jul 20, 2022 | Audits, Blog, Certificates, Classification, Compliance, Consulting Group, COVID-19, Documents, Engineering, EU, EU MDR, FDA, Guidance, Inspections, Pharma, Pharmaceuticals, Quality, Quality Systems, Recall, Registration, Regulatory, Requirements, Risk Management, Safety, Standardization, Standards, Testing, Tools, Updates, Verification

When I began my adventures in compliance with the European Regulation on Medical Devices ((EU) 2017/745)¹ or EU MDR, in mid-2019, pre-pandemic, I was struggling to understand (as were my colleagues) how to address the regulation’s ANNEX II, Section 4, General Safety and Performance Requirements (now often referred to as the “GSPR”), item (c), whichreads as follows:

“The documentation shall contain information for the demonstration of conformity… The demonstration of conformity shall include: … (c) the harmonised standards, CS or other solutions applied.”

A ‘CS’ was to be a ‘Common Specification,’ intended to satisfy the EU MDR requirements. If you were working to comply with the EU’s Regulation on in vitro Diagnostic Medical Devices ((EU) 2017/746)², or EU IVDR, the equivalent to a CS was referred to as a ‘CTS’ (“Common Technical Specification”).

The understanding was that all other types of technical documents, harmonized or otherwise, were going to need to be accompanied by rationale for adequacy in lieu of the preferred CS (or CTS), specifically:

“Manufacturers shall comply with the CS … unless they can duly justify that they have adopted solutions that ensure a level of safety and performance that is at least equivalent thereto.”³

My regulatory colleagues and I reached out to one another, mostly through focused LinkedIn Groups, with questions like: “Do you know if there is any CS (or CTS) document for <insert your general technical requirement description here> yet?” The answer was always: “No.,” “Not yet.” or “I don’t know.” It was frustrating for even the most seasoned regulatory pros.

Today, the EU MDR website⁵ boasts about fifty guidance documents published since mid-2019 and recognized by the EU’s Medical Device Coordinating Group or MDCG. Included among them is one published in April 2021, MDCG 2021-5, “Guidance on standardisation for medical devices”.⁶

Fortunately, the question of what constitutes “the equivalent to an EU MDR Common Specification” may no longer be quite as daunting. Today, there is no longer a need to try to figure it out all alone. The regulatory community has been working hard to figure out what works to demonstrate EU MDR and EU IVDR technical compliance for the past 2 to 3 years.

Let us help! EMMA International and I can assist you with identifying technical compliance requirements for your specific device or can help you develop an entire regulatory compliance program for your organization. Contact us by phone at 248-987-4497 or by sending an email to: info@emmainternational.com.

_{¹European Regulation on Medical Devices ((EU) 2017/745), accessed in English, on 07/19/2022 from: Consolidated TEXT: 32017R0745 — EN — 05.05.2017 (europa.eu); NOTE: to access the text in other languages, visit: EUR-Lex – 02017R0745-20170505 – EN – EUR-Lex (europa.eu)}

_{²European Regulation on in vitro Diagnostic Medical Devices ((EU) 2017/746), accessed in English, on 07/19/2022 from: https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32017R0746&from=EN; NOTE: to access the text in other languages, visit: EUR-Lex – 32017R0746 – EN – EUR-Lex (europa.eu)}

_{³ EU MDR Article 9 Description of Common Specifications, accessed 07/19/2022 from: https://www.medical-device-regulation.eu/tag/common-specification/}

_{⁵ EU MDR MDCG Guidance Publications, retrievable via the EU MDR website, published since mid-2019 (and prior): https://eumdr.com/}

_{⁶MDCG 2021-5, Guidance on standardisation for medical devices, April 2021, retrieved from: MDCG 2021-5 Guidance on standardisation for medical devices (europa.eu)}

Diane Kulisek

Ms. Kulisek serves as a Senior Quality Engineer and Senior Regulatory Affairs Specialist for EMMA International’s Technical Operations team. She has experience in technical writing, quality management systems, regulatory enforcement remediation, corrective and preventive action management, electronic data management systems, cybersecurity, and design controls for the medical device industry. Ms. Kulisek also has significant past experience in quality engineering and management for mass-produced consumer products, electronics, aerospace and commercial filtration industries. Ms. Kulisek holds a Master of Science in Engineering with a concentration in Civil, Industrial and Applied Mechanical Engineering Management from California State University, Northridge (CSUN) and a Bachelor of Arts in Biology with a concentration in Environmental Biology, also from CSUN. She also holds a Graduate Certificate in Program Management from West Coast University, a Lean Six Sigma Green Belt from Six Sigma Systems, Inc., and Certifications for multiple EU MDR and EU IVDR topics from Greenlight Guru. Ms. Kulisek maintained American Society for Quality Certifications for more than twenty consecutive years as a Quality Engineer (ASQ CQE) and as a Manager of Quality / Organizational Excellence (ASQ CMQ/OE).